Method and apparatus for sharps protection

ABSTRACT

Devices and methods are disclosed for protecting individuals from the sharp ends of medical objects following use on a patient. Such sharp objects include hypodermic needles, scalpel blades, cannulae, trocars, and the like. The protective cover is designed to surround and sequester the sharp in a shell that is will not permit further puncture or cutting with the sharp. In an embodiment, the protective cover also absorbs any fluids on or in the used sharp and prevents any fluids from escaping the protective cover. The devices are configured to be integral to procedure trays or kits such that space and discarded materials are minimized along with the potential for injuring someone with a used, contaminated medical sharp.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/191,218, filed Jun. 23, 2016, now U.S. Pat. No. 10,835,687, issuedNov. 17, 2020, which claims the priority benefit of U.S. ProvisionalApplication Ser. No. 62/183,967, filed Jun. 24, 2015, which are herebyincorporated in their entirety herein by reference.

FIELD

This invention relates to devices and methods to protect individualsfrom infectious disease spread due to cuts and puncture wounds made bysharp, contaminated objects. More particularly, the invention relates toa protective container for safely sequestering and disposing of usedmedical sharps.

BACKGROUND

Pathogenic microorganisms may be present in human blood, body fluids orother infected materials and can cause infection and disease in personswho are percutaneously, or mucocutaneously, exposed. These pathogensinclude, but are not limited to, hepatitis B virus (HBV), hepatitis Cvirus (HCV) and human immunodeficiency virus (HIV). In this context,contaminated blood, body fluids or other infected materials may mean thepresence or reasonably anticipated presence of pathogenic microorganismson the surface or in a device.

A medical sharp is an object that can penetrate the skin and includesdevices such as, but not limited to, needles, scalpels, tubes, wires,and other medical procedure objects, devices or instruments. Accidentalinjury or puncture with contaminated, sharp needles or surgicalinstruments, referred to as medical sharps or sharps, remains asignificant risk to healthcare workers. All healthcare workers, such asphysicians, nurses, paramedics, emergency medical technicians, ambulancestaff, airmedics, airmedic staff technicians, janitorial staff, officestaff, and even patients and their families are potentially at risk fromthis dangerous situation.

Typically, injuries resultant from accidental needle and scalpel sticksoccur after the instruments have been used. As a result, healthcareworkers are subject to serious diseases, including but not limited tohepatitis B virus (HBV), hepatitis C virus (HCV) and humanimmunodeficiency virus (HIV).

Most often, needle and scalpel punctures occur during the handling ofused sharp instrumentation prior to permanent disposal. Healthcareworkers can accidentally stick themselves or others in the vicinitywhile carrying contaminated instruments to a centrally located disposalcontainer for used sharps. Often, needles dangerously protrude from thedesignated container, often located on a peripheral wall of a given roomand often located behind furniture, fixtures, and medical equipment.This increases the risk of puncture to the healthcare worker placing thesharp in the container, or emptying the used sharps container.

The true cost of the problem is difficult to measure. For every“needlestick” exposure, the health care worker is subjected to batteriesof tests that are repeated 3 to 4 times over the following year. If therisk is determined to be substantial, in terms of exposure to known orlikely HIV, Hepatitis, or other pathogens, there may also be medicationcosts involved. There are side effects to medications administered forsuspected disease transmission and the costs, both societal andmonetary, are significant for such treatments. If a disease is actuallytransmitted by the event, the costs, both personal and financial, arestaggering, and the event can prove to be career ending as well asadversely affecting the family and social life of the healthcare worker.Disease transmission, in the worst scenario, can be life ending for theexposed healthcare worker. Bearers of these costs, both tangible andintangible, include health care organizations, their insurers,governmental agencies, the health care workers and their families, andsociety as a whole.

Current solutions in the prior art include needle guards and covers,retractable needles, scalpel protectors and needleless connectingsystems for intravenous solutions.

Although needle guards and covers, needles and needleless systemsaddress part of the solution to the problem, they do not offer auniversal solution that will manage the risks posed by other types ofmedical sharps, including scalpel blades, trocars, and the like.

A typical sharps collector and disposal device is a mailbox-stylecontainer with or without a pull-down opening allowing access to thecontainer. The user pulls the lid open, deposits the used sharp, andreleases lid, which swings shut, much like mailing a letter.Mailbox-style containers without the pull-down opening have a tortuouspath that the sharp must traverse to enter the container. Themailbox-style containers can be found in a variety of sizes and uses,such as in-hospital room containers, multi-purpose containers, mail-awaycontainers, large volume and pharmacy containers, specializedcontainers, transportable containers, and the like.

A typical problem with mailbox-style receptacles is that they arefrequently overfilled with needles, such that the needles stick out ofthe container opening. In addition, it may be difficult to put certaintypes of sharps, such as butterfly needles, needles attached tosyringes, suture needles, trocars, cannulae, and the like, into them. Anoverfilled mailbox-style receptacle may result in healthcare workersbecoming cut and infected by an already disposed-of sharp when they tryto insert a new sharp into the receptacle and force their hand on theprotruding sharp object, or by the new sharp itself. An additional riskof the mailbox-style receptacle includes the user being stuck as thesharp is being placed into the unit due to the difficulty of insertingthe sharp into the tortuous pathway opening.

Not only are health care workers themselves at risk because ofinadequate or unsafe disposal systems, but there are significant risksto housekeeping personnel within healthcare institutions and even to thepublic, who may encounter an improperly disposed, contaminated,unprotected, medical sharp device. Areas at risk include in-patienthospitals, outpatient facilities, emergency or ambulatory facilities,patient homes, offices, public restrooms, physician's offices, nursinghomes, laboratories, emergency medical facilities, military facilities,helicopters, airplanes, airmedic facilities, employer facilities,hospice care facilities, needle dispensing facilities for heroin addictsand diabetics, and the like. Unprotected contaminated medical sharps areoccasionally found in public areas such as public beaches, parks, andchildren's play areas.

New devices, procedures, systems, and methods are needed for guarding,dispensing, and collecting contaminated sharps to minimize the risk ofaccidental wounding of healthcare workers and others by infectious,sharp devices. Such devices and procedures are particularly important inany medical setting including in-hospital, pre-hospital, outpatient,military, and the emergency department.

SUMMARY

This invention relates to devices to minimize the risk of injury andinfectious disease spread from one individual to another due to injuriesor puncture wounds made by sharp, contaminated objects.

The apparatus described herein is termed a Sharpshell although this termis used without limitation or functional constraint throughout only forconvenient reference to the apparatus of the present invention. TheSharpshell can comprise a rigid or semi-rigid shell that is punctureresistant to syringe needles, scalpel blades, suture needles and thelike, under normally anticipated loading. The Sharpshell can comprise atop, or upper, portion and a bottom, or lower, portion. The top portioncan be affixed to the bottom portion by means of a hinge or otherconnector. The top portion can be closed against the bottom portion tocreate a closed shell. The closed shell can comprise an internal volumecapable of holding sharps. When closed, the top portion can abut thebottom portion at an interface. In some embodiments, the interfacebetween the top portion and the bottom portion can comprise a seam. Insome embodiments, when the shell is closed, the seam can be blocked by agate that crosses the seam between the top portion and the bottomportion to prevent a sharp medical device from projecting out of theshell across the seam. The gate, or gates, can be integral or affixed tothe top portion, the bottom portion, or both the top and bottomportions.

In some embodiments, the Sharpshell can comprise a lock. The lock can beconfigured to secure the top portion to the bottom portion, afterclosure. The lock can be permanent and irreversible, or it can beconfigured as reopenable. Activation of the lock, or even closure of thetop portion against the bottom portion, in some embodiments, can cause asecondary lock to clamp serrated or sharp edges down onto sharpsinserted into the Sharpshell, thus ensuring that they cannot be removedbecause a mechanical interlock has been generated.

In some embodiments, the Sharpshell can comprise internal high-frictionmaterials to minimize the risk of the entrapped medical sharp movingonce placed therein. Such high-friction materials can comprise top orbottom foam pads or other structures exposed therein.

In some embodiments, the Sharpshell can comprise a seal, or a pluralityof seals, configured to prevent the escape of fluid from the internalvolume of the shell. The seal can be affixed proximate to the perimeterof the shell to prevent fluid from escaping through the interfacebetween the top portion and the bottom portion. A seal can also beaffixed at or near a window area to prevent fluid leakage through thewindow, whether or not one or more medical sharp projects therethrough.

In some embodiments, the top portion, the bottom portion, or bothportions of the shell can comprise substantially transparent materialsso that items trapped within the shell can be visualized by a user.

In some embodiments, the Sharpshell can comprise a needle countingpattern or structure. Needles can be inserted into or through the needlecounting pattern or structure. The needle counting pattern or structurecan facilitate a clear observation of the presence and number of itemsinserted or placed therein. The needle counting pattern or structure canbe affixed to a foam pad. The foam pad can be sandwiched betweenstructures after closure of the shell. In other embodiments, the needlecounting pattern or structure can be positioned adjacent to atransparent exterior wall of the shell so that the number of sutureneedles enclosed therein can be observed and counted, even after theshell has been closed.

In certain embodiments, the Sharpshell can comprise a needle removalmechanism. A hypodermic needle, attached to a syringe barrel by, forexample, a Luer lock or slip Luer mechanism, can be inserted into theneedle removal mechanism and then be safely removed from the syringebarrel by the user without risking injury. The needle removal mechanismcan comprise a rigid bulkhead or rib, affixed to the Sharpshell suchthat a syringe needle can be inserted into a hole or a slot, gripped bythe hole or slot such that the needle hub cannot rotate, and thenremoved from the syringe barrel by rotating the syringe barrel todisengage the Luer mechanism connecting the syringe barrel to the Luerlock syringe. Friction generating mechanisms can be comprised by theneedle removal mechanism to resist or prevent the needle from backingout of the Sharpshell, once inserted. Beneficial features include one ormore bulkhead or rib being substantially rigid and firmly affixed to theSharpshell either on the interior (preferred) or the exterior. The holeor slot is beneficially visible to the user for precise alignment andengagement of the needle. The hole or slot can, in some embodiments,comprise a lead-in, funnel, or tapered entry path to guide or direct thesharp needle into the hole or slot to minimize difficulties inperforming this procedure. The needle removal mechanism, in someembodiments, can be located generally proximate an end or side region ofthe Sharpshell shell and can be comprised by a window into the shell ofthe Sharpshell.

In other embodiments, the Sharpshell can be configured with a firstinternal volume that is sealed against fluid leakage, and a secondinternal volume that retains protruding blunt ends of medical sharps butdoes not prevent fluid leakage. A needle removal mechanism can becomprised or affixed to the interface between the sealed and non-sealedinternal regions.

In other embodiments, the Sharpshell can comprise a scalpel controlmechanism affixed to the Sharpshell in the same, or similar, fashion asthe needle removal mechanism. The scalpel control mechanism can beconfigured to break the scalpel blade from the handle, to bend thescalpel blade to prevent removal, embed the scalpel blade in a foam, gelor other block of material, or the like.

In other embodiments, the Sharpshell system can be built into a sterileprocedure tray. The Sharpshell can be affixed to the tray, it can restwithin a region or space assigned for the Sharpshell, or it can befabricated integral to the tray, itself. The Sharpshell can comprise atear away portion of the procedure tray that provides for a small,compact structure that is more easily handled and disposed of withinproper waste facilities than would be an entire procedure tray.

For purposes of summarizing the invention, certain aspects, advantagesand novel features of the invention are described herein. It is to beunderstood that not necessarily all such advantages may be achieved inaccordance with any particular embodiment of the invention. Thus, forexample, those skilled in the art will recognize that the invention maybe embodied or carried out in a manner that achieves one advantage orgroup of advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

These and other objects and advantages of the present invention will bemore apparent from the following description taken in conjunction withthe accompanying drawings.

Summary of Several Embodiments of the Invention

The present inventions may be understood through a description of itsseveral features and characteristics, any of which may be included inits several embodiments independently so as to bring about the benefitsthereof.

The present inventions may be understood by reference to the Figuresthat are intended as representative examples without limitation to otherembodiments and variations that will be apparent to one of ordinaryskill from the present disclosure.

Summary of a First Embodiment Exemplified by FIG. 1

An embodiment includes an apparatus adapted for entrapment and disposalof medical sharps comprising: (a) a shell having a first shell portionand a second shell portion; and (b) a hinge portion between the firstshell portion and the second shell portion adapted to permit the firstshell portion and the second shell portion to be moved between a first,open position and a second, closed position wherein the shell in theclosed position defines a storage volume; (c) a high-friction padenclosed within the storage volume when the shell in the closed positionadapted to resist the dislodgement of an entrapped medical sharp onceplaced therein; and (d) an adhesive disposed so as to maintain the shellin the closed position.

The apparatus may additionally comprise an adhesive on the high-frictionpad, and a releasable cover piece covering the high-friction pad, andmay have the releasable cover piece comprise a releasable adhesivestrip.

In one variation, the high-friction pad comprises a first portion havingan upper surface and affixed to the first shell portion and a secondportion having an upper surface and affixed to the second shell portion.One embodiment may additionally comprise an adhesive on the uppersurface of the first portion, and may further include a releasable coverpiece covering the adhesive on the upper surface of the first portion.In another variation, the apparatus may additionally include an adhesiveon the upper surface of the second portion, and a releasable cover piececovering the adhesive on the upper surface of the second portion.

Summary of a Second Embodiment Exemplified by FIG. 2

An embodiment further includes an apparatus adapted for entrapment anddisposal of medical sharps comprising: (a) a shell having a first shellportion and a second shell portion; (b) a hinge portion between thefirst shell portion and the shell second portion adapted to permit thefirst shell portion and the second shell portion to be moved between afirst, open position and a second, closed position wherein the shell inthe closed position defines a storage volume, the first shell portionand the second shell portion comprising interferant structure adapted tomaintain the shell in the closed position, and the first shell portionand the second shell portion when in the closed position forming anopening located along an edge of at least one of the first shell portionand the second shell portion, the opening configured to allow the sharpend of a medical sharp to project into the storage volume; and (c) ahigh-friction pad enclosed within the storage volume when the shell inthe closed position adapted to resist the dislodgement of an entrappedmedical sharp once placed therein.

One embodiment may additionally comprise a plurality of engagementfeatures disposed in the opening and shaped so as to grip the hub of aneedle.

Another embodiment may additionally comprise a releasable cover piececovering the high-friction pad, and this may be a releasable adhesivestrip.

In one variation, the high-friction pad may comprise a first portionhaving an upper surface and affixed to the first shell portion and asecond portion having an upper surface and affixed to the second shellportion. This variation may also comprise a releasable cover piececovering the upper surface of the first portion and a releasable coverpiece covering the upper surface of the second portion. The releasablecover pieces may comprise a releasable adhesive strip.

Summary of a Third Embodiment Exemplified by FIG. 3

An embodiment also includes an apparatus adapted for entrapment anddisposal of medical sharps comprising: (a) a shell having a first shellportion and a second shell portion; (b) a hinge portion between thefirst shell portion and the shell second portion adapted to permit thefirst shell portion and the second shell portion to be moved between afirst, open position and a second, closed position wherein the shell inthe closed position defines a storage volume, the first shell portionand the second shell portion comprising interferant structure adapted tomaintain the shell in the closed position, and the first shell portionand the second shell portion when in the closed position forming anopening located along an edge of at least one of the first shell portionand the second shell portion, the opening configured to allow the sharpend of a medical sharp to project into the sealed volume, and the firstshell portion and the second shell portion forming a flexible collarportion around the opening when the shell is in the closed position; and(c) a high-friction pad enclosed within the storage volume when theshell in the closed position adapted to resist the dislodgement of anentrapped medical sharp once placed therein.

In one embodiment, the first shell portion and the second shell portioneach comprise a flexible material extension that mate to form theflexible collar portion when the shell is in the closed position.

One variant may include additionally a plurality of engagement featuresdisposed in the opening and shaped so as to grip the hub of a needle.

Another variation additionally comprises a releasable cover piececovering the high-friction pad, which may be a releasable adhesivestrip.

In another variation, the high-friction pad comprises a first portionhaving an upper surface and affixed to the first shell portion and asecond portion having an upper surface and affixed to the second shellportion; and this may additionally include a releasable cover piececovering the upper surface of the first portion and a releasable coverpiece covering the upper surface of the second portion, which releasablecover pieces may comprise a releasable adhesive strip.

Summary of a Fourth Embodiment Exemplified by FIG. 4

An embodiment further includes an apparatus adapted for entrapment anddisposal of medical sharps comprising: (a) a shell having a first shellportion and a second shell portion; (b) a hinge portion between thefirst shell portion and the shell second portion adapted to permit thefirst shell portion and the second shell portion to be moved between afirst, open position and a second, closed position wherein the shell inthe closed position defines a storage volume, the first shell portionand the second shell portion comprising interferant structure adapted tomaintain the shell in the closed position; and (c) a high-friction padenclosed within the storage volume when the shell in the closed positionadapted to resist the dislodgement of an entrapped medical sharp onceplaced therein, the high-friction pad having a first relatively thinportion and a second relatively thin portion, whereby the high-frictionpad accommodates an assembled syringe barrel and needle being supportedthereupon by the first relatively thin portion being in contact with thebarrel of the syringe and the second relatively thin portion being incontact with the barrel of the syringe.

In one embodiment, the apparatus additionally comprises an adhesivedisposed on the high-friction pad, which optionally additionallycomprises a releasable cover piece covering the high-friction pad, thereleasable cover piece in one variant comprising a releasable adhesivestrip.

In another embodiment, the high-friction pad has an upper surface isaffixed to the first shell portion and additionally comprises a secondhigh-friction pad having an upper surface affixed to the second shellportion. A variant of this embodiment involves the additional inclusionof an adhesive disposed on the upper surface of each the high-frictionpad, with or without a releasable cover piece on the upper surface ofeach the high-friction pad.

Summary of a Fifth Embodiment Exemplified by FIG. 5

An embodiment further includes an apparatus adapted for entrapment anddisposal of medical sharps comprising: (a) a shell having a first shellportion and a second shell portion; (b) a hinge portion between thefirst shell portion and the shell second portion adapted to permit thefirst shell portion and the second shell portion to be moved between afirst, open position and a second, closed position wherein the shell inthe closed position defines a storage volume, the first shell portionand the second shell portion comprising interferant structure adapted tomaintain the shell in the closed position, and the first shell portiondefining an opening in the shell when in the closed position, theopening configured to allow the sharp end of a medical sharp to projectinto the sealed volume; and (c) a high-friction pad adapted to resistthe dislodgement of an entrapped medical sharp once placed therein, andhaving a first portion enclosed within the storage volume when the shellin the closed position, and a second portion disposed so as to beexposed through the opening.

In one embodiment, the second portion is disposed below the firstportion at an angle to the first portion when the shell second portionrests on a supporting surface.

In another embodiment, the apparatus additionally comprises an adhesiveon the high-friction pad, and a releasable cover piece covering thehigh-friction pad, which releasable cover piece may comprise areleasable adhesive strip.

In still another embodiment, the apparatus additionally comprises areleasable cover piece disposed on the bottom of the second shellportion and of sufficient length to be extended over the medical sharpextending from the opening in the shell when in the closed position, andto be adhered to the first shell portion.

Summary of a Sixth Embodiment Exemplified by FIG. 6

An embodiment also includes an apparatus adapted for entrapment anddisposal of medical sharps comprising: (a) a shell having a first shellportion and a second shell portion; (b) a hinge portion between thefirst shell portion and the shell second portion adapted to permit thefirst shell portion and the second shell portion to be moved between afirst, open position and a second, closed position wherein the shell inthe closed position defines a storage volume, the first shell portionand the second shell portion when in the closed position forming anopening located along an edge of at least one of the first shell portionand the second shell portion, the opening configured to allow the sharpend of a medical sharp to project into the storage volume, the firstshell portion and the second shell portion each comprising a flexibleextension forming a flexible collar around the opening when in theclosed position, the having an adhesive-bearing inner surface, and areleasable cover piece on the adhesive-bearing inner surface; (c) ahigh-friction pad enclosed within the storage volume when the shell inthe closed position adapted to resist the dislodgement of an entrappedmedical sharp once placed therein; and (d) an adhesive disposed so as tomaintain the shell in the closed position.

In one embodiment, the high-friction pad is affixed to the shell secondportion and the pad having a first portion and a second portion andwherein first portion is disposed at an angle to the second portion whenthe shell second portion rests on a supporting surface.

Summary of a Seventh Embodiment Exemplified by FIG. 7

An embodiment further includes an apparatus adapted for entrapment anddisposal of medical sharps comprising: (a) a shell having a first shellportion and a second shell portion; (b) a hinge portion between thefirst shell portion and the shell second portion adapted to permit thefirst shell portion and the second shell portion to be moved between afirst, open position and a second, closed position wherein the shell inthe closed position defines a storage volume, the first shell portionand the second shell portion when in the closed position forming anopening located along an edge of at least one of the first shell portionand the second shell portion, the opening configured to allow the sharpend of a medical sharp to project into the storage volume, the firstshell portion and the second shell portion each comprising a flexibleextension forming a flexible collar around the opening when in theclosed position, the having an adhesive-bearing inner surface, and areleasable cover piece on the adhesive-bearing inner surface; (c) ahigh-friction pad enclosed within the storage volume when the shell inthe closed position adapted to resist the dislodgement of an entrappedmedical sharp once placed therein, wherein the high-friction padcomprises a first portion having an upper surface and affixed to thefirst shell portion and a second portion having an upper surface andaffixed to the second shell portion; and (d) an adhesive disposed so asto maintain the shell in the closed position.

In one embodiment, the apparatus additionally comprises a releasablecover piece disposed over the adhesive.

In another embodiment, the apparatus according additionally comprises asharp-penetration-resistant sleeve disposed on the side of the firstportion opposite its upper surface, and a sharp-penetration-resistantsleeve disposed on the side of the second portion opposite its uppersurface, or only on either of these surfaces.

In yet another embodiment, the high-friction pad comprises a firstportion having an upper surface and affixed to the first shell portionand a second portion having an upper surface and affixed to the secondshell portion, and wherein the adhesive is disposed upon at least one ofthe surfaces, and in one variant may additionally comprises a releasablecover piece disposed over the adhesive, such as a releasable adhesivestrip.

In another variant the adhesive is disposed upon both of the uppersurfaces and additionally comprising a releasable cover piece coveringthe upper surface of the first portion and a releasable cover piececovering the upper surface of the second portion, and optionally each ofthe releasable cover pieces may comprise a releasable adhesive strip.

Summary of an Eighth Embodiment Exemplified by FIG. 8

An embodiment also includes an apparatus adapted for entrapment anddisposal of medical sharps comprising: (a) a shell having a first shellcontainer portion having an opening, and a second shell lid portion; and(b) a hinge portion between the first shell container portion and theshell second lid portion adapted to permit the first shell containerportion and the second shell lid portion to be moved between a first,open position and a second, closed position wherein the shell in theclosed position defines a storage volume, the first shell containerportion and the second shell lid portion comprising interferantstructure adapted to maintain the shell in the closed position, and thefirst shell portion and the second shell lid portion each containing ahigh-friction pad adapted to resist the dislodgement of an entrappedmedical sharp once placed therein; wherein the edge portion of theopening comprises an engagement feature disposed in the opening andshaped so as to grip the hub of a syringe needle, and wherein the firstshell container portion is adapted to stand upright and wherein thefirst shell container portion is of sufficient length to contain asyringe needle when extended therein and its hub is engaged by theengagement feature, and wherein the storage volume is of sufficientlength to contain a syringe needle and syringe needle hub when the shellin the closed position.

In one embodiment, the apparatus additionally comprising an adhesive onthe high-friction pad contained in second shell lid portion, and areleasable cover piece covering the adhesive, and this may be areleasable adhesive strip.

Summary of a Ninth Embodiment Exemplified by FIG. 9

An embodiment further includes an apparatus adapted for entrapment anddisposal of medical sharps comprising: a shell defining storage volume,the shell having a top portion, a side wall portion and a bottom baseportion, the base portion being at least as large in area as the topportion, the shell adapted to stand upright upon the base so as topresent an exposed the top portion and an exposed the side wall portion;the top portion comprising (a) at least one syringe cap holding apertureadapted to releasably accept a syringe cap so as to allow a cappedsyringe to be releasably extended into the storage volume and (b) atleast one syringe capture aperture adapted to capture and hold a syringehub as its syringe needle extends into the storage volume; and whereinthe shell comprises a suture needle aperture adapted to receive sutureneedles into the storage volume. In different variants, this embodimentof the invention may have only the syringe cap holding aperture, or onlythe syringe capture aperture.

In one embodiment, the side wall portion comprises the suture needleaperture, and in one variation the apparatus may additionally comprise ahigh-friction pad contained within the shell and the friction pad beingexposed through the at least one syringe capture and the suture needleaperture.

In another embodiment, the side wall portion comprises the suture needleaperture, and one variant features a releasable cover piece covering thesuture needle aperture which may be a releasable adhesive strip.

In a further embodiment, the base portion is of a material adapted toresist sliding friction as compared to the material comprised by the atop portion and side wall portion. As an alternative, the entire shellmay be made from the same material, which is resistant to slidingfriction

Summary of a Tenth Embodiment Exemplified by FIG. 10

An embodiment further includes an apparatus adapted for entrapment anddisposal of medical sharps comprising: a shell defining storage volume,the shell having a top portion, a side wall portion, a bottom wallportion and a base portion, the base portion adapted to rest upon asupporting surface so as to present an exposed the top portion and anexposed the side wall portion, with the bottom wall portion supportedabove the supporting surface; the top portion comprising a suture needleaperture; the side portion comprising and (a) at least one syringecapture aperture adapted to capture and hold a syringe Luer fitting asits syringe needle extends into the storage volume; and (b) a scalpelaperture adapted to receive and secure scalpel blades into the storagevolume; and an extension panel extending below the bottom wall portionwhen it is supported above the supporting surface, the extension panelcomprising a syringe cap holding aperture adapted to releasably accept asyringe cap so as to allow a capped syringe to be releasably extendedtherethrough and astride the bottom wall portion. In different variants,this embodiment of the invention may have only the syringe captureaperture, or only the scalpel aperture.

One embodiment involves the base portion comprising the extension panel.

In another embodiment, the syringe cap holding aperture has a centralaxis, and additionally comprises a blocking wall portion extendingacross the central axis, to prevent the syringe cap from being extendedfurther than operationally required to permit the syringe cap to beplaced and removed during a procedure. The base portion may include thisblocking wall portion.

In still another embodiment, the syringe cap holding aperture has acentral axis, and additionally comprises a blocking wall portionextending across the central axis, and a secondary wall portion disposedat an angle to the blocking wall portion; and wherein the base portioncomprises the extension panel, the blocking wall portion and thesecondary wall portion.

One variation involves additionally including a releasable cover piececovering the suture needle aperture, which may be a releasable adhesivestrip.

Summary of an Eleventh Embodiment Exemplified by FIG. 11

An embodiment also includes an apparatus adapted for entrapment anddisposal of medical sharps comprising: (a) a shell having a firstportion comprising (1) a top portion and (2) at least three side wallportions, and an extension panel, and a second portion comprising (1) abottom wall portion (2) at least three side wall portions and (3) a baseportion; and (b) a hinge between the first portion and the secondportion adapted to permit the first portion and the second portion to bemoved between a first, open position and a second, closed positionwherein the shell in the closed position defines a storage volume andpositions the base portion so as to rest upon a supporting surface so asto present an exposed the top portion, an exposed bottom portion and oneof the side wall portions, with the bottom wall portion supported uponthe supporting surface; and wherein: the storage volume of the bottomportion optionally comprising a foam or foam-like insert adapted toreleasably accept a suture needle; the side wall portion comprising (a)at least one syringe capture aperture adapted to capture and hold asyringe Luer fitting as its syringe needle extends into the storagevolume; and (b) a scalpel aperture adapted to receive and secure scalpelblades into the storage volume; and an extension panel extending belowthe top portion when the shell is in an open position and is supportedabove the supporting surface, the extension panel comprising a syringecap holding aperture adapted to releasably accept a syringe cap so as toallow a capped syringe to be releasably extended therethrough andastride the top wall portion. In different variants, this embodiment ofthe invention may have only the syringe capture aperture, or only thescalpel aperture.

In one embodiment, the base portion comprises the extension panel.

In another embodiment, the syringe cap holding aperture has a centralaxis, and additionally comprises a blocking wall portion extendingacross the central axis, to prevent the syringe cap from being extendedfurther than operationally required to permit the syringe cap to beplaced and removed during a procedure. The base portion may include thisblocking wall portion.

In yet another embodiment, the syringe cap holding aperture has acentral axis, and additionally comprises a blocking wall portionextending across the central axis, and a secondary wall portion disposedat an angle to the blocking wall portion; and wherein the base portioncomprises the extension panel, the blocking wall portion and thesecondary wall portion.

This hinged design does not have a suture needle aperture in the topportion like the unhinged variant shown in Figure. Instead, the sutureneedles may be are inserted into foam (or another high-frictionmaterial) that fills the larger bottom portion.

Summary of a Twelfth Embodiment Exemplified by FIG. 12

An embodiment also includes an apparatus adapted for entrapment anddisposal of medical sharps comprising: a shell defining storage volume,the shell having a top portion, a side wall portion and a bottom baseportion, the base portion being at least as large in area as the topportion, the shell adapted to stand upright upon the base so as topresent an exposed the top portion and an exposed the side wall portion;the top portion comprising (a) at least one syringe cap holding apertureadapted to releasably accept a syringe cap so as to allow a cappedsyringe to be releasably extended into the storage volume and (b) atleast one syringe capture aperture adapted to capture and hold a syringehub as its syringe needle extends into the storage volume; and (c) asuture needle and scalpel aperture adapted to receive suture needles andscalpel blades into the storage volume. In different variants, thisembodiment of the invention may have only the syringe cap holdingaperture, only the syringe capture aperture, or only the scalpelaperture.

In one embodiment, the apparatus additionally comprises a high-frictionpad contained within the shell and which high-friction pad is exposedthrough the at least one syringe capture and/or the suture needleaperture, and this may include a releasable cover piece covering thesuture needle and scalpel aperture, which releasable cover piece maycomprise a releasable adhesive strip.

In another variant, the base portion is of a material adapted to resistsliding friction as compared to the material comprised by the a topportion and side wall portion, or the entire shell may be made of suchmaterial.

Additionally an adhesive pad may be included in the base portion totemporarily attach the base portion to the procedure tray or table.

Summary of a Thirteenth Embodiment Exemplified by FIG. 13A-13E

The present embodiment further includes an apparatus adapted forentrapment and disposal of medical sharps comprising: a shell definingstorage volume, the shell having a top portion, a side wall portion anda bottom base portion, the base portion being at least as large in areaas the top portion, the shell adapted to stand upright upon the base soas to present an exposed the top portion and an exposed the side wallportion; the top portion comprising (a) at least one syringe cap holdingaperture adapted to releasably accept a syringe cap so as to allow acapped syringe to be releasably extended into the storage volume and (b)at least one syringe capture aperture adapted to capture and hold asyringe hub as its syringe needle extends into the storage volume; andwherein the shell comprises a suture needle aperture adapted to receivesuture needles into the storage volume, and (c) at least one scalpelblade window in the top portion.

In one embodiment, the side wall portion comprises the suture needleaperture, and in one variation the apparatus may additionally comprise ahigh-friction pad contained within the shell and exposed through atleast one the syringe capture and the suture needle aperture.

In another embodiment, the side wall portion comprises the suture needleaperture, and one variant features a releasable cover piece covering thesuture needle aperture which may be a releasable adhesive strip.

In still another embodiment, the suture needle aperture may extend intoboth the top portion and side wall portion.

In a further embodiment, the base portion is of a material adapted toresist sliding friction as compared to the material comprised by the atop portion and side wall portion, or the entire shell may be made ofsuch material.

The present invention includes all medical, clinical or surgical uses ofthe apparatus embodiments and variants of the present invention, as wellas generally for the attachment, containment or entrapment and disposalof any hazardous materials or items to which the apparatus embodimentsand variants of the present invention might find beneficial application.

Any of the apparatus embodiments of the present invention may becontained within a procedure tray or kit, or may be affixed to aprocedure tray or kit, for any given medical, clinical or surgicalprocedure involving the use of medical sharps.

An embodiment includes medical, clinical or surgical post-procedureinvolving the use of any of the apparatus embodiments and variants ofthe present invention for the attachment, containment or entrapment anddisposal of contaminated medical sharps, including without limitation,sutures, scalpels and syringes.

An embodiment further includes performing these methods within theexamination or treatment room, office or operating suite where any givenmedical, clinical or surgical procedure involving the use of medicalsharps occurs.

The method may also include optionally disposing of contaminated medicalsharps entrapped or contained in any of the apparatus embodiments andvariants of the present invention, such as by placing the apparatusembodiments and variants of the present invention in another sharpsdisposal container, such as any of those known in the art.

A method for attachment, containment or entrapment and disposal ofcontaminated medical sharps comprises generally the steps of providing,at the point of use or contamination, any of the apparatus embodimentsand variants of the present invention in a sterile package, removing itfrom the sterile package, placing it in the sterile field in an positionso as to expose the areas or spaces for sharps insertion, attachment orentrapment, inserting used/contaminated medical sharps into theapparatus of the present invention, sealing, closing, adhering themedical sharps as the case may be through action of the apparatus of thepresent invention, and disposing of the apparatus of the presentinvention bearing the attached, contained or entrapped contaminatedmedical sharps.

The method may also include optionally the step of providing theapparatus of the present invention within a procedure tray or kit, suchas by affixing it to the procedure tray or kit.

The method may also include optionally the step of separating theapparatus of the present invention from the procedure tray or kit afterthe apparatus has been filled with medical sharps and closed to attach,contain or entrap contaminated medical sharps.

The method may also include optionally the further step of preventingremoval of medical sharps from the apparatus of the present invention byclamping down on the inserted medical sharp with a jam cleat or jawapparatus.

One variation of the method for entrapment and disposal of contaminatedmedical sharps comprises generally the steps of: providing, at the pointof use, a container comprising a puncture resistant shell, wherein thepuncture-resistant shell comprises a first portion, a second portion,and a pre-defined hinge separating the first portion from the secondportion and allowing the first portion to rotate about an axis such thatthe first portion can be brought into apposition against the secondportion, and a window; wherein the window comprises apparatus configuredfor removal and retention of medical sharps inserted therethrough;removing the container from a sterile package; placing the container inthe sterile field with the first portion rotated away from the secondportion such that the shell is open; inserting used medical sharps intothe shell, through the window; grabbing the medical sharps within thewindow; removing handles, barrels, or other grasping components from themedical sharps; and preventing removal of the medical sharps from thewindow area.

The method may also include optionally the step of providing thepuncture resistant shell within a procedure tray or kit, such as byaffixing it to the procedure tray or kit.

The method may also include optionally the step of separating thepuncture resistant shell from the procedure tray or kit after theapparatus has been filled with medical sharps and closed to attach,contain or entrap contaminated medical sharps.

The method may also include optionally the further step of preventingremoval of medical sharps from the window area by clamping down on theinserted medical sharp with a jam cleat or jaw apparatus.

BRIEF DESCRIPTION OF THE DRAWINGS

A general architecture that implements the various features of theinvention will now be described with reference to the drawings. Thedrawings and the associated descriptions are provided to illustrateembodiments of the invention and not to limit the scope of theinvention. Throughout the drawings, reference numbers are re-used toindicate correspondence between referenced elements.

FIG. 1A illustrates an oblique view of an open Sharpshell H comprisingcurvilinear surfaces, a flat bottom, which can comprise a slightlycurvilinear contour, and transparent shell materials, according to oneembodiment;

FIG. 1B illustrates an oblique view of the Sharpshell device of FIG. 1Afollowing closure of the top portion against the bottom portion,according to one embodiment;

FIGS. 1C-10 provide additional views of the Sharpshell of FIGS. 1A and1B.

FIG. 2A illustrates an oblique view of an open Sharpshell A comprising ashell having upper or top portion and bottom or lower portion, a lowerlayer of foam, an upper layer of foam, a puncture-resistant shell,projections and receivers positioned at the end of the interface betweenthe upper and bottom portions of the shell, and an opening configured toentrap and retain medical sharps inserted therethrough;

FIG. 2B illustrates an oblique view of the closed Sharpshell of FIG. 2A,comprising an opening configured to stabilize, entrap, and retain thehub of hypodermic needles inserted therethrough, according to oneembodiment;

FIGS. 2C-2L provide additional views of the Sharpshell of FIGS. 2A and2B.

FIG. 3A illustrates an oblique view of an open Sharpshell B comprisingthe elements of the apparatus of FIG. 2A but with the addition of adeformable collar surrounding the opening, according to one embodiment;

FIG. 3B illustrates an oblique view of the Sharpshell of FIG. 3A in theclosed configuration, according to one embodiment;

FIGS. 3C-3L provide additional views of the Sharpshell of FIGS. 3A and3B.

FIG. 4A illustrates an oblique view of an open Sharpshell C comprising atwo part shell separated by a hinge and including an internal volumesufficiently large to completely entrap a hypodermic needle and syringebarrel according to one embodiment;

FIG. 4B illustrates an oblique view of the Sharpshell of FIG. 4A in theclosed configuration, according to one embodiment;

FIGS. 4C-4L provide additional views of the Sharpshell of FIGS. 4A and4B.

FIG. 5A illustrates an oblique view of an open Sharpshell D comprising atwo part shell separated by a hinge and including a lower sharpscollection pad, a lid, and a shroud to overlap and contain theprotruding blunt ends of medical sharps, according to one embodiment;

FIG. 5B illustrates an oblique view of the Sharpshell of FIG. 5A in theclosed configuration, according to one embodiment;

FIGS. 5C-5N provide additional views of the Sharpshell of FIGS. 5A and5B.

FIG. 6A illustrates an oblique view of an open Sharpshell comprising atwo part shell separated by a hinge and a rounded exterior cross-sectionwith a lower collection pad that protrudes into the top portion and acollapsible adhesive collar around an opening to the collection pad,further comprising a beveled collection pad on the end that is distal tothe adhesive collar, according to one embodiment of the invention;

FIG. 6B illustrates an oblique view of the Sharpshell of FIG. 6A in theclosed configuration wherein suture needles in the counting region arevisible through a beveled portion of the clear top portion and whereinthe collar can be folded inward to secure any medical sharps projectingout of the collection pad through the opening, according to oneembodiment;

FIGS. 6C-6P provide additional views of the Sharpshell of FIGS. 6A and6B.

FIG. 7A illustrates an oblique view of an open Sharpshell F comprising ashell and a lid separated by a hinge with a suture needle counting andcollection pad within the lid of the shell and an opening to the centralvolume of the shell, the housing of the opening being affixed to theshell, the opening further comprising features for removing medicalsharps from their handles or barrels, according to one embodiment;

FIG. 7B illustrates an oblique view of the Sharpshell of FIG. 7A in theclosed configuration wherein the top has been closed to encase thesharps and the opening, according to one embodiment;

FIGS. 7C-7M provide additional views of the Sharpshell of FIGS. 7A and7B.

FIG. 8A illustrates an oblique view of an open Sharpshell G comprising ahard or semi-hard shell, a hollow internal volume with an optional foaminternal pad, a ring around the hub grabbing element which comprisesadhesive protected by release paper, and a lid separated by a hinge witha suture needle counting an collection pad within the lid of the shelland an opening to the central volume of the shell, the housing of theopening being affixed to the shell, the opening comprising features forgrabbing and removing medical sharps from their handles or barrels,according to one embodiment;

FIG. 8B illustrates an oblique view of the Sharpshell of FIG. 8A in theclosed configuration wherein the top has been closed, according to oneembodiment;

FIGS. 8C-8M provide additional views of the Sharpshell of FIGS. 8A and8B.

FIG. 9A illustrates an oblique view of a Sharpshell comprising aninverted, flared, axially elongate shell, a closed top, bottom and sidesurfaces, features for hypodermic needle exchange, suture needlecounting and retention area, and syringe needle entrapment and removalfeatures, according to one embodiment;

FIG. 9B illustrates a top view of the Sharpshell of FIG. 9A showing theneedle exchange and needle removal mechanism in more detail, accordingto one embodiment;

FIGS. 9C-9G provide additional views of the Sharpshell 900 of FIGS. 9Aand 9B.

FIG. 10 illustrates a Sharpshell comprising rectilinear geometry andstability enhancing standoffs, a non-openable central volume, andfeatures to accept syringe needles, suture needles, and scalpels,according to one embodiment;

FIG. 11 illustrates a Sharpshell comprising a bottom portion, anopenable top portion, and features to accept scalpels, needle exchangecap, and syringe needle hubs, according to one embodiment; and

FIG. 12 illustrates a non-openable Sharpshell comprising an axiallyelongate structure with curvilinear sides, a wide base, and features toaccept suture needles, scalpels, and hypodermic needles, according toone embodiment.

FIG. 13A illustrates an oblique view of a Sharpshell comprising aninverted, flared, axially elongate shell, a closed top, bottom and sidesurfaces, features for hypodermic needle exchange, suture needlecounting and retention area, and syringe needle entrapment and removalfeatures, according to one embodiment of the invention;

FIG. 13B illustrates a top view of the Sharpshell of FIG. 13A showingthe needle exchange and needle removal mechanism in more detail,according to one embodiment of the invention;

FIGS. 13C-13E provide additional views of the Sharpshell 1300 of FIGS.13A and 13B.

DETAILED DESCRIPTION

In accordance with one or more embodiments of the present invention, aplurality of embodiments of a Sharpshell system is described herein. Inorder to fully specify this preferred design, various embodimentspecific details are set forth, such as the shape and size of thereceptacle as well as the dispenser. It should be understood, howeverthat these details are provided only to illustrate the presentedembodiments, and are not intended to limit the scope of the presentinvention.

FIG. 1A illustrates an oblique view of an open Sharpshell 100 comprisinga bottom portion 102 further defining a first portion of an interiorvolume 118, a top portion 104 further defining a second portion of aninterior volume 120 (the interior volumes 118 and 120 defining theinterior volume of the Sharpshell 100 when in the closed position shownin FIG. 1B), a bottom lip 108, a top lip 106, a hinge 110, a flat bottom112, a foam receiver pad 114, and a label 116. The Sharpshell 100 canfurther comprise a needle or scalpel hub release mechanism.

Referring to FIG. 1A, the bottom shell 102 is affixed to the top portion104 by the hinge 110, which can be affixed (or integral) to the bottomportion 102, the top portion 104, or both. The foam receiver pad 114 canbe placed in whole or in part within the interior volume 118 of thebottom portion 102 or it can be affixed to one or more of the interiorwalls of the bottom portion 102. The foam receiver pad 114 can beretained within the bottom portion 102 by friction, compression,adhesion or the like. The bottom lip 108 and the top lip 106 can beformed integrally, or affixed to, to the bottom portion 102 and the topportion 104 respectively. In an embodiment, there is no foam within thevolume of the top portion. In other embodiment, the top portion volume118 is filled, wholly or at least in part, by foam. In anotherembodiment, the bottom portion lip 106 can comprise a receiver while thetop portion lip 108 comprises a projection that mates with the bottomportion receiver, serving as a gate to block passage of any sharp objectthrough the interface between the bottom lip 108 and the top lip 106.The projection and the receiver can be formed integrally to the top lip106 and bottom lip 108 respectively. The Sharpshell 100 can furthercomprise a suture needle counting region or receiver 122.

The label 116 can be affixed to the foam receiver pad 114 usingadhesives or it can be directly printed thereon. The label 116 cancomprise images of suture needle counting areas, or the like. In otherembodiments, a recapping and needle exchange mechanism can be comprisedby a structure affixed within the foam receiver pad 114. The re-cappingstructure can comprise features similar or the same as to of ahypodermic needle cover or cap. In other embodiments, the recappingneedle exchange mechanism may allow for temporary holding of ahypodermic needle cover or cap.

The top portion 104, the bottom portion 102, and the hinge 110, whichhenceforth shall be characterized as the shell, can be fabricated byprocesses such as, but not limited to, thermoforming, injection molding,or the like. The shell can comprise materials such as, but not limitedto, polyester (PET), polyimide (Nylon), poly amide, polypropylene,polyethylene (PE), high density polyethylene (HDPE) polyether etherketone (PEEK), polyurethane (PU), polyvinyl chloride (PVC), polysulfone,polyacetal, acrylic, copolymers of the aforementioned, or the like. Theshell can further comprise additional layers of cellulose or otherlaminates or composites of the aforementioned. The materials chosen areconsidered for their puncture resistance to sharp medical devices suchas, but not limited to, scalpel blades, hypodermic needles, sutureneedles, and the like. The shell materials are configured to resistpuncture with the aforementioned devices under normal manipulation andforces encountered in handling. The shell materials described above areusable for all of the embodiments described within this specification.

In a preferred embodiment, the top portion 104 is visually transparentto allow the user to observe the presence and count the numbers ofsutures, needles, scalpels, or other medical sharps contained therein.In another embodiment, the end of the shell away from the flat end 112comprises an opening or window further comprising a needle hub, ascalpel blade, or both, detachment mechanism. In a preferred embodiment,the bottom 112 can be slightly curvilinear, rather than beingsubstantially flat.

FIG. 1B illustrates an oblique view of the closed Sharpshell 100. Theclosed Sharpshell 100 comprises the top portion 104, the bottom portion102, the top lip 106, the bottom lip 108, and the hinge 110. Theconstruction includes curvilinear central portion (i.e., 102 a and 104a) with a flattened end cap (i.e., 102 b and 104 b) at one end and aflange lip (i.e., 102 c and 104 c) protruding outward and surroundingthe end cap at the other end.

Referring to FIG. 1B, in an embodiment, the closed shell in thisexemplary embodiment is approximately 1.5 to 2.0 inches wide,approximately 2 to 4 inches long, and about 1 to 2 inches thick. Thesize of the closed shell is such that the closed Sharpshell fits easilywithin the human hand and can be transported securely and disposed ofusing existing sharps disposal containers, such as by being placedtherein. The shell material in this exemplary embodiment may have athickness ranging from about 0.01 to about 0.10 inches, with a preferredthickness of about 0.02 to about 0.06 inches with a more preferred rangeof about 0.03 to about 0.05 inches.

In the illustrated embodiment, the bottom portion 102 and the topportion 104 are curvilinear in longitudinal cross-section. In otherembodiments, the bottom portion 102 and/or the top portion 104 cancomprise flat or rectilinear surfaces which can enhance stability andfacilitate placement on a table, suture tray, procedure kit, or thelike.

When closed, the Sharpshell top portion 104 can lock to the bottomportion 102 by way of interference tabs or locks which are locatedproximate the flanges 106 and 108. The interference tabs are affixed orintegrally formed with the flanges of top lip 106 and bottom lip 108, orsome other portion of the shell, such that male portions of theinterference tabs project into and lock with complementary structuresintegral to the female portions of the interference tabs. Theseinterference tabs can connect the top portion 104 to the bottom portion102 with a tactile and audible snap that confirms closure and preventsre-opening.

The foam or pad 114 can comprise the receiver or counting region 122 forthe placement of suture needles. This receiver or counting region 122can be disposed such that it is visible through the closed shell. Thereceiver or counting region 122 can be disposed such that it is situatedup against a top portion 104 of the closed shell 100 or it can be spacedaway from the envelope of the shell.

Additional views of the Sharpshell 100 are provided in FIGS. 1C-10wherein like numerals refer to the features and portions describedabove.

FIG. 1I-1K shows the top portion 104 to the bottom portion 102 such asin the form of a clear plastic shell, top portion 104 being a lid withlabel indicia, and which may be provided with a blister packagecovering, as well as optional tab 124 with peel off adhesive label. ThisFigure also shows that the bottom portion 102 may contain a cardboardtube containing a foam center portion, as the foam or pad 114, and thatthe shell may be a clear plastic material.

This allows used suture needles to be inserted from above into the foampad in numbered targets for accounting purposes, while syringe needlesand scalpels may be inserted at the top of the device as shown in latterFIGS. 1M-1N.

FIG. 1L shows how entrapped suture needles are visible through the clearlid of 104.

FIGS. 1M-1N show the insertion of syringe needles in the closed shellfrom above. FIG. 1M shows a top oblique view of the Sharpshell 100showing the foam center portion marked to direct users when insertingsharps, with scoring to accommodate scalpels.

FIG. 1M shows an elevation oblique view of the Sharpshell 100 showingthe insertion of sharps into the top foam portion of the device.

FIG. 1N shows an elevation oblique view of the Sharpshell 100 showingthe insertion of sharps into the top foam portion of the device forfurther processing and/or disposal.

FIG. 2A illustrates an oblique view of another embodiment of an openSharpshell 200 comprising an top portion shell 216, a bottom portionshell 204, a hinge 214, an upper foam layer 210, a lower foam layer 232,an upper volume 226, a lower volume 228 (the top or upper volume 226 andbottom or lower volume 228 defining the interior volume of theSharpshell 200 when in the closed position shown in FIG. 2B), an openingor window 208, a needle removal mechanism 230 (See FIG. 2B), a pluralityof needle removal features 212, a projecting engagement feature 220, arelease paper 224, and a projection receiver 218 (See FIG. 2B).

Referring to FIG. 2A, this embodiment is somewhat larger in length andwidth than the device of FIG. 1A as described above. The needle removalfeatures 212 can be affixed to, or integral with, the window 208. Theneedle removal features 212 can be affixed to, or integral with, thewindow needle removal mechanism 230.

The lower foam pad 232 comprises labeling which can include sutureneedle counting targets 232A, syringe orientation guides 232B, optionalsyringe needle recapping features, and the like. The upper foam pad 210can comprise biohazard labeling 210A, instructions for use 210B, safetyinstructions 210C, and the like. The upper foam pad 210, the lower foampad 232, or both can optionally comprise adhesive to assist withretention of sharps placed within the Sharpshell 200. The adhesives canbe pressure sensitive and can further comprise a release paper 224,which is removed prior to inserting used medical sharp devices withinthe Sharpshell 200. The release paper 224 can comprise a lift tab foreasy grip and/or labeling such as instructions for use, warnings, andthe like. The release paper 224 can comprise a siliconized paper orpolymer structure. The adhesive can be affixed as a laminate to the foampads 210, 232, or it can be applied as a liquid or aerosol spraythereto. The adhesives can comprise materials such as, but not limitedto, cyclohexane, 2-methylpentane, isobutene, propane, dimethyl ether,3-methlpentane, 2,3 dimethylbutane, 2,2 dimethylbutane, hexane,polyurethane, and the like.

The opening 208 allows syringes, scalpels, or the like, to be insertedtherein such that the needle hub removal features 212 can grip the hubof the hypodermic needle. The needle removal features 212 are configuredto grip the polymeric hub of the hypodermic needle and permit friction,polymeric blocking or interference fit therein and prevention of rotarymotion of the hypodermic needle hub while the hypodermic syringe barrelcan be unscrewed therefrom and detached. In an embodiment, the needleremoval features 212 comprise star shaped or cross-shaped fenestrationsinto which the needle hub, comprising star or cross-shaped projectionscan be inserted and gripped. In another embodiment, the needle removalfeature 212 can comprise a plurality of teeth-like inserts that protrudeinto the needle removal feature 212 into which the needle hub can beinserted and gripped. Preferably the needle removal mechanism 212 isfabricated from rigid materials that can reliably grip the polymeric hubof the hypodermic needle and permit friction.

The needle shaft removal mechanisms 230, which can be located proximatethe opening 208 are configured to grasp or grip the shaft of thehypodermic needle or scalpel and prevent or resist removal of aninserted needle or scalpel. The needle shaft removal mechanism 230 can,in an embodiment, comprise a jam-cleat function the splits open easilyupon insertion of the medical sharp therethrough but closes against themedical sharp with increasing force as the medical sharp is withdrawnproximally. The needle shaft removal mechanism 230 can comprise metal orpolymeric planar structures that are split radially and can be bent orcurved distally away from the point of entry of the medical sharp. Asmall fenestration, hole, or window, smaller in diameter than that ofthe envisioned hypodermic needle, can be located within the slit tofacilitate insertion of the medical sharp. Preferably the needle shaftremoval mechanism is fabricated from extremely hard metals that can diginto the stainless steel shaft of the hypodermic needle or scalpelblade. Once inserted, proximal withdrawal of the syringe needle causesthe split, sharp metal surfaces to dig into the syringe needle withincreasing force as the hypodermic needle is withdrawn, thus preventingwithdrawal.

In other embodiments, a braided tubular structure can be comprisedwithin the opening 208. The braided tubular structure can furthercomprise aggressive adhesives on its interior to grab a syringe needle.The braided tubular structure is affixed to the opening 209 at itsdistal end farthest from the window. Proximal withdrawal of the syringeneedle causes the braided tubular structure to reduce in diameter andgrab the syringe needle, thus preventing its withdrawal. The braidedtubular structure can comprise metallic or polymeric materials.

The materials of the Sharpshell 200 can be similar to, or the same as,those of the Sharpshell 100 of FIG. 1A.

FIG. 2B illustrates an oblique view of a closed Sharpshell 200comprising a shell 202 further comprising a bottom portion 204, an topportion 216, an interface 206 between the top portion 216 and the bottomportion 204, a projecting gate receiver 218 in the top portion 216, aprojecting gate 220 (See FIG. 2A) in the bottom portion 204, a hinge214, and an opening 208. The Sharpshell 200 further comprises an innervolume 226+228 when the top portion is closed against the bottomportion. The Sharpshell 200 also comprises, a label 222, a needle hubreceiver 212 (See FIG. 2A) located within the opening 208 and furthercomprising one or more hub grasping features configured to resideadjacent or within the needle removing feature 212.

Referring to FIG. 2B, the top portion 216 is affixed to the bottomportion 204 by the hinge 204, which can be integral or affixed to thetop portion 216, the bottom portion 204, or both. The opening 208comprises an operable entry into the inner volume 222 through which thesharp ends of hypodermic needles can be inserted into the inner volume222. The hubs of the hypodermic needles are used to releasably connectthe hypodermic needle to a syringe barrel, generally by way of a slipLuer or Luer lock adapter. Such connections can also be made usingthreaded adapters, bayonet mounts, quick connects, or the like. The hubreceiver 212, in the illustrated embodiment comprises a series ofgrooves arrayed in a star or cross-pattern. A needle hub can be insertedinto the receiver 212 until the hub of the needle undergoes aninterference fit with the receiver 212. The star or cross pattern canfurther grab a complementary star or cross feature on the needle hubsand permit unscrewing or release of the syringe barrels. The opening 208can further comprise an elastomeric membrane which serves to seal theopening 208 if the needle is withdrawn for any reason. The opening 208can, in other embodiments, comprise a hardened, sprung jam-cleat thatcomprises a center hole or plurality of slits, or both, such that ahypodermic needle can be inserted therethrough but upon withdrawing ofthe hypodermic needle, the jam cleat closes with increasing tightnessaround the needle and prevents its removal.

The shell 202 is substantially puncture-resistant to hypodermic needlesand scalpel blades and can comprise polymeric materials, organic fibermaterials, metals, or a combination thereof in the form of laminates orextra layers. For example, a fiberboard liner can be disposed within thetop portion 216, the bottom portion 204, or both to enhance theresistance to sharp penetration through the walls of the Sharpshell.

The dimensions of the closed Sharpshell 200 can range from approximately1.5 to 4.0 inches wide, approximately 2 to 6 inches long, and about 0.5to 2 inches thick.

The opening 208 can comprise an optional guard, shield, frame, flange,or boss, which surrounds the opening 208 and defines the window region.

The adhesive is configured such that when the top portion 216 is closedagainst the bottom portion 204, the adhesive can grip the shaft of aninserted sharp and assist with retention. The adhesive further acts as alocking mechanism to assist in retaining the top portion 216 closedagainst the bottom portion 204.

In other embodiments, the Sharpshell 200 can comprise an optionalirreversible lock. The irreversible lock includes features that preventgrabbing the lock to disengage it. In yet other embodiments, the lockcan be reversible such that the lock can be grasped and opened. The lockcan comprise features such as a tab, oversnap, latch, threaded feature,or the like.

The projection and the receiver serve not only to block penetration ofthe interface by a medical sharp when the shell is closed, but alsoserves to enhance the fluid-tight seal of the shell when the Sharpshellis closed. Furthermore, a polymeric, elastomeric membrane can be affixedwithin the Sharpshell, preferably in the region of the opening 208 toserve as a seal to prevent any leakage through the opening 208.

Additional views of the Sharpshell 200 are provided in FIGS. 2C-2Lwherein like numerals refer to the features and portions describedabove.

FIG. 21 shows that the top portion 216 may be provided with a blisterpackage covering.

FIG. 2J shows that the bottom portion 204 may contain a cardboard liningor equivalent material beneath the foam pad contained therein, as shownin FIG. 2K.

FIG. 2K shows the release paper 224 with adhesive release tab. From thisFigure one can also appreciate how hub receiver 212 may provide a moldedengagement structure to allow the Luer locks 241 to be snapped intoplace and held while the syringe barrels are disconnected.

FIG. 21 shows how syringes 240 may be placed so as to engage hubreceiver 212 as the syringe needles extend into the Sharpshell 200. Thesyringe barrels may then be removed while the syringe Luer locks 241remain secured in hub receiver 212 as shown in FIG. 2J.

FIG. 3A illustrates a Sharpshell apparatus 300 in the open configurationcomprising an top portion 302, a bottom portion 304, a hinge 306, alower foam layer 308, a lower label area 310, an upper form area 312, anupper label area 314, an opening 316, a sharps detachment mechanism 318,and a deformable collar system 320, further comprising a collar support322 and a collar 324. The top portion 302 and the bottom portion 304comprise all or a portion of a shell 326.

FIG. 3B illustrates the Sharpshell apparatus 300 in the closedconfiguration. The Sharpshell 300 comprises a shell 326, furthercomprising the top portion shell 302 and the bottom portion shell 304,and an internal volume 328. The collar 324 has been deformed inward andpressed against the collar support 322 such that a trapped sharp isrestrained by the collapsed collar 324.

Referring to FIG. 3B, the deformable collar 324 can comprise flexiblematerials. The deformable collar 324 can comprise polymeric materials.The deformable collar 324 can be affixed to the top portion 302, thebottom portion 304, or both. The deformable collar 324 can compriseadhesives affixed to interior surfaces of the deformable collar 324 tofacilitate grabbing and holding any medical sharps projectingtherethrough. The deformable collar 324 can comprise construction thatassumes a first relaxed, open shape, a second, high energy state, and athird relaxed state. The collar 324 can be forced past the high energystate configuration to achieve the third relaxed state, which ispreferably a closed or semi-closed configuration. This high energy statecan be achieved with the use of elastomers, semi-rigid or rigidmaterials, or the like. The deformable collar 324 can be sized to grabthe sides of projecting medical sharps or it can be sized to completelyencapsulate the length and even the ends of medical sharps. In yet otherembodiments the deformable collar 324 can be replaced or augmented by astrap that is affixed to the shell 326 and wraps around the end ofprojecting medical sharps and then can be affixed to the shell 326 at asecond (or same) location. Such a strap can comprise adhesive orfriction generating materials or properties. The purpose of thedeformable collar 324 is to irreversibly lock or secure a medical sharpto the Sharpshell 300. The collar support 322 can comprise rigidmaterials and be configured to snap the collar 324 across itshigh-energy second configuration and into the third, low energyconfiguration.

The needle removal apparatus 318 can be affixed proximate the opening316. The syringe needle removal system 318 can be configured similarlyto other sharp detachment mechanisms described herein.

Additional views of the Sharpshell 300 are provided in FIGS. 3C-3Lwherein like numerals refer to the features and portions describedabove.

FIG. 31 shows that the upper label area 314 may be provided with ablister package covering.

FIG. 3J shows that the bottom portion shell 304 may contain a cardboardlining or equivalent material beneath the foam pad contained therein, asshown in FIG. 3K.

FIG. 3K shows the release paper 224 with adhesive release tab. From thisFigure one can also appreciate how sharps detachment mechanism 318 mayprovide a molded engagement structure to allow the Luer locks 341 to besnapped into place and held while the syringe barrels are disconnected.

FIG. 31 shows how syringes 340 may be placed so as to engage sharpsdetachment mechanism 318 as the syringe needles extend into theSharpshell 300. The syringe barrels may then be removed while thesyringe Luer locks 341 remain secured in sharps detachment mechanism 318as shown in FIG. 3J.

FIG. 4A illustrates a Sharpshell apparatus 400 in the openconfiguration. The Sharpshell apparatus 400 comprises a bottom portion404, and top portion 402, defining a shell 426 having an internal volume428, and a hinge 406. The Sharpshell apparatus 400 further comprises alower pad 408, further comprising a step 430, an upper pad 412, a lowerpad label 410, and an upper pad label 414. The lip of the bottom portion402 further comprises a gate feature 416 that fits into a complementarygate feature 418 on the top portion 404.

Referring to FIG. 4A, the step 430 permits insertion of a hypodermicneedle or other medical sharp while keeping the handle or barrel roughlyparallel to the plane of the lower shell portion 404. The top portion402 and the bottom portion 404 are sufficiently large as to completelyenclose a pre-defined range and number of syringe barrels, scalpelblades, or the like.

The lower pad label 410 can comprise a needle counting area with aplurality of boxes and numbers, letters, or the like. The lower padlabel 410 can also comprise images of sharps such as syringes orscalpels to illustrate the orientation of insertion, cautions, warnings,instructions, and the like.

FIG. 4B illustrates the Sharpshell apparatus 400 comprising the topportion 402, the bottom portion 404, and the hinge 406. The top portion402 has been rotated about the hinge 406 and closed against the bottomportion 404 to form an internal volume (not visible). There are nowindows in the top portion 402 or the bottom portion 404 and nothingprojects out of the Sharpshell 400. The Sharpshell 400 is configured tocompletely enclose a medical sharp and any handles, barrels, or the likesuch that no part of the used medical device projects beyond theboundaries of the shell 426. The exterior of the shell 426 can compriseone or more labels 420 including descriptions, warnings, cautions,instructions, and the like.

The Sharpshell 400 can further comprise openable or irreversible locksto maintain closure once the upper shell portion 402 is closed againstthe bottom portion 404. Such locks can comprise snaps with edges thatare hidden and cannot be grasped for re-opening, adhesive closuresystems, snaps that grab and lock with no opening structures, and thelike.

The Sharpshell 400 can further comprise edge seals to prevent fluidleakage out through the interface between the top portion 404 and thebottom portion 402. The edge seals can comprise mechanisms such as, butnot limited to, close-fitting structures, gaskets, adhesive layers, andthe like. The edge seals can be integrated into the gate features 416,418, or both.

The Sharpshell 400 can further comprise gates 418, 416 surrounding aportion, or all, of the perimeter of the top portion 402, the bottomportion 404, or both. The gates 418, 416 can be configured to projectacross the interface between the bottom portion 404 and the top portion402 to prevent a sharp device from projecting out across the interface.The gates can be affixed, or integral, to the top portion 402, thebottom portion 404, or both. The gates can be fabricated from the same,or different, puncture resistant materials as the top portion 402 andthe bottom portion 404.

Additional views of the Sharpshell 400 are provided in FIGS. 4C-4Lwherein like numerals refer to the features and portions describedabove.

FIG. 4I shows the exterior of the shell 426 with label indicia.

FIG. 4J shows that the bottom portion shell 404 may contain a cardboardlining or equivalent material beneath the foam pad 430 containedtherein, as shown in FIG. 4K.

FIG. 4K shows how syringes 440 may be placed in bottom portion 404 so asto be completely contained in the Sharpshell 400 once closed. Thesyringe barrels are accommodated by the step-down taper of the foam pad430 contained therein.

FIG. 5A illustrates a Sharpshell apparatus 500 in the openconfiguration. The Sharpshell apparatus 500 comprises a shell 526,further comprising a bottom portion 504, a top portion 502, an internalvolume 528, and a hinge 506. The Sharpshell apparatus 500 furthercomprises a lower pad 508, further comprising an angled syringe orscalpel target 530, an exterior shell label 514, an adhesive layer 534,a cover strip 532, a securing strap 512, and a lower pad label 510.

Referring to FIG. 5A, the adhesive layer 534 is affixed to the topportion lid 502. The release paper or cover strip 532 covers theadhesive layer 534 and is removed before closing the lid or top portion502.

Referring to FIG. 5A, the target 530 is disposed at an angle to theplanes of the shell 526 to allow for stability against a flat surfacebut the ability to insert medical sharps into the lower pad 508, throughthe target 530. The shell 526 can be transparent, translucent, oropaque.

Labels 510 can comprise instructions for use, suture needle countingpatterns, orientation of syringes or scalpels, warnings, cautions, orthe like.

The top portion 502 can comprise the strap 512, which can be pulled outfrom the bottom portion 504 and secured to the top portion 502.

The pad 508 can comprise open-cell absorbent foam, gel, adhesive or thelike.

FIG. 5B illustrates the Sharpshell 500 of FIG. 5A in the closedposition. The Sharpshell 500 comprises the bottom portion shell 504 andthe top portion shell 502, which is a lid. The adhesive layer 534 locksthe lid or top portion 502 down against the bottom portion 504. Thestrap 512 can be pulled around the extents of a projecting blunt handleof a medical sharp to secure the handle to the Sharpshell apparatus 500at the top portion 502. The strap 512 can be secured with a lock, snap,fastener, adhesive, or the like by the user and is preferablypre-secured to the shell 526, either by affixation or integralconstruction. The shell 526 can comprise a shroud 524 that surrounds thetarget area 530.

In one embodiment, bottom portion 504 may be provided on its bottom witha plastic wrapper that may be released by release tab 535 which wrapperand or tab may be provided with adhesive so as to be wrapped about theclosed Sharpshell apparatus 500 to cover the target area 530 once havingengaged scalpels and/or syringes for disposal.

The perimeter of the top portion 502 and the bottom portion 504 can beconfigured to seal to each other to prevent fluid leakage around theperimeter. The target area 530 can comprise a membrane or gasket toprevent fluid leakage out through the target area 530 even with medicalsharps projecting therethrough.

The shroud 524 can comprise rigid or flexible materials and can furthercomprise adhesive interior surfaces. The shroud 524 can be configured tocollapse inward from a first low energy configuration, across a second,high energy configuration to a third, low energy, closed configuration.

Additional views of the Sharpshell 500 are provided in FIGS. 5C-5Nwherein like numerals refer to the features and portions describedabove.

FIG. 5I shows the bottom portion shell 504 and the top portion shell502, which is a lid with label indicia, and which may be provided with ablister package covering.

FIG. 5J shows that the target 530 is disposed at an angle to the planesof the shell 526 to allow for stability against a flat surface but theability to insert medical sharps into the lower pad 508, through thetarget 530. This allows suture needles to be inserted from above intothe foam pad, while syringe needles and scalpels may be inserted at anangle.

FIG. 5K shows a lower oblique view of the shell 526 with bottom portion504 provided on its bottom with a plastic wrapper that may be releasedby release tab 535 which wrapper and or tab may be provided withadhesive so as to be wrapped about the closed Sharpshell apparatus 500to cover the target area 530 once having engaged scalpels and/orsyringes for disposal.

FIG. 5L shows an upper oblique view of the shell 526.

FIG. 5M shows a progression of views showing (1) the opening of theshell 526, and removal of the cover by tab 512 to expose the adhesivetarget area and to expose the target area 530 for insertion of medicalsharps 540, (2) the closure of the top portion 502 to close shell 526with pressure to seal, (3) the untaping of the plastic wrapper by tab535 which then (4) is wrapped around the shell 526 to capture medicalsharps 540 with the adhesive tab sticking to the top of top portion 502to be secured for further processing and/or disposal.

FIG. 6A illustrates an oblique view of an open Sharpshell 600 comprisinga first portion 602 of a shell 612, a second portion 604 of the shell612, a hinge 606, a collection pad 608, a beveled collection pad facet614, and a collapsible collar or shroud 610.

Referring to FIG. 6A, the first portion 602 and the second portion 604of the shell 612 comprise a rounded exterior cross-section. Thecollection pad 608 can comprise an oblique facet 614 on one end. Thecollection pad 608 is affixed to one of the shell portions and protrudesinto the other portion. The collection pad 608 is illustrated as beingaffixed or inserted into the second portion 604. The collapsible collar610 can be affixed to one or more portions 602, 604, and surrounds anopening 616 to the collection pad 608.

The collection pad 608 is fabricated from materials that areenvironmentally friendly, such as cellulose or other biodegradablematerials. The shell 612 can be fabricated from puncture resistantmaterials and can be opaque, translucent, or substantially transparentso as to be able to visualize the contents. Due to the materialsselection, the Sharpshell 600 is generally larger in dimensions that theSharpshell 100, although they are similar in configuration. The facet614 can comprise a suture needle counting area or other features.

The collection pad 608 can further comprise a syringe needle exchangemechanism, feature, or structure, integrally formed therein or affixedthereto. Such syringe needle exchange mechanism can be comprised by anyof the Sharpshell devices described within this specification.

FIG. 6B illustrates an oblique view of the Sharpshell 600 in the closedconfiguration wherein suture needles in a counting region printed ontothe oblique portion 614 (see FIG. 6A) of the collection pad 608 can berendered visible through a clear region 620 comprising some, or all, ofthe shell portion 602. The collar 610 can be folded inward to secure anymedical sharps projecting out of the collection pad through the opening616. The collar 610 can be affixed to the first portion 602, the secondportion 604, or both.

Referring to FIG. 6B, the interior of the collar 610 can compriseadhesives or other friction generating structures to retain any sharpscontained therein.

The collapsible collar 610 can comprise adhesive internal surfaces orsurfaces comprising high friction, such as soft rubbers or siliconeelastomers. The collapsible collar 610 can comprise a high-energy statethrough which it is manually forced to move it from a first, open, lowenergy state to a third close, low energy state.

Additional views of the Sharpshell 600 are provided in FIGS. 6C-6Pwherein like numerals refer to the features and portions describedabove.

FIG. 6I shows the first portion 602 and the second portion 604, which isa lid with label indicia, and which may be provided with a blisterpackage covering, as well as the collar 610. This Figure also shows thatthe second portion 604 may contain a cardboard tube with a foam centerportion, and that the shell may be a clear plastic material. The collar610 is shown with a peel-off adhesive label.

FIG. 6J shows that the oblique portion 614 is disposed at an angle tothe planes of the shell 608 to allow for stability against a flatsurface but the ability to insert medical sharps into oblique portion614. This allows used suture needles to be inserted from above into thefoam pad in numbered targets for accounting purposes, while syringeneedles and scalpels may be inserted at the top of the device as shownin latter Figures. This view also shows the removal of the adhesivelabel prior to the folding of the first portion 602.

FIG. 6K shows an upper oblique view of the shell 608 after the adhesivelabel is removed, the adhesive label being colored or provided withindicia to caution users when inserting sharps.

FIG. 6L shows an upper oblique view of the shell 608 after first portion602 is folded over.

FIG. 6M shows a top oblique view of the shell 608 showing the foamcenter portion marked to direct users when inserting sharps, withscoring to accommodate scalpels.

FIG. 6N shows an elevation oblique view of the shell 608 showing theinsertion of sharps into the top foam portion of the device.

FIG. 6O shows an elevation oblique view of the shell 608 showing theinsertion of sharps into the top foam portion of the device, and theclosure of the adhesive collapsible collar 610 about the inserted sharpsfor further processing and/or disposal.

FIG. 7A illustrates an oblique view of an open Sharpshell 700 comprisinga bottom shell 702 and a lid 704 operably connected by a hinge 706. Thebottom shell 702 comprises a suture needle counting and collection pad708. The shell 702 comprises an opening 710 to a central volume 712 ofthe shell 702, the opening 710 being affixed to the shell 702. Theopening 710 can comprise features 714 for removing medical sharps fromtheir handles or barrels. A secondary pad 716 can optionally becomprised within the central volume 712.

FIG. 7B illustrates an oblique view of the Sharpshell 700, in the closedconfiguration, wherein the top or lid 704 has been closed against theshell 702 to encase the sharps and the window region 710.

Referring to FIG. 7B, the shell 702, the lid 704, or both, can beopaque, translucent, or substantially transparent so as to be able tovisualize the contents. The shell 702 can be fabricated from punctureresistant materials such as, but not limited to, fiberboard or otherenvironmentally friendly materials and can be generally non-transparent.The shell 702 and the lid are fabricated from materials and structuresthat are puncture-resistant to medical sharps under normal handlingconditions. The interface between the lid 704 and the shell 702 canoptionally comprise a fluid-tight seal or gasket. A gate between the lid704 and shell 702 can also be provided to keep suture needles fromprotruding through any interface.

Additional views of the Sharpshell 700 are provided in FIGS. 7C-7Gwherein like numerals refer to the features and portions describedabove.

FIG. 7G shows the shell 702 and the lid 704, the shell may be made frommolded pulp with infused resin in the main shaded area for punctureresistance.

FIG. 7H shows the suture needle counting and collection pad 708. Thisallows used suture needles to be inserted from above into the foam pad708 in numbered targets for accounting purposes, while syringe needlesand scalpels may be inserted at the top of the device as shown in latterFigures. This view also shows the device prior to removal of theadhesive label and prior to folding the lid 704.

FIG. 7H shows an upper oblique view of the shell 702 and the lid 704after the adhesive label is removed. The shell 702 and/or the lid 704also may be provided with adhesive to maintain the device in the closedposition after the shell 702 and the lid 704 are folded together.

FIG. 7J shows an upper oblique view of the shell 702 after the lid 704is folded over. This view shows the foam center portion marked to directusers when inserting sharps, with scoring to accommodate scalpels.

FIG. 7K shows an elevation oblique view of the shell 702 showing theinsertion of sharps into the top foam portion of the device.

FIG. 7L shows an elevation view of the shell 702 showing the insertionof sharps into the top foam portion of the device, and the closure ofthe adhesive collapsible collar about the inserted sharps for furtherprocessing and/or disposal.

FIG. 8A illustrates an oblique view of an open Sharpshell 800 comprisinga hard or semi-hard shell 802, a hollow internal volume 812 with anoptional foam internal pad 808, a hinge 806, a hub grabbing element 814which comprises adhesive protected by release paper 816, and a lid 804separated by the hinge 806 with a suture needle counting an collectionpad 808 within the lid 804, and an aperture 818 operably opening to thecentral volume 812 of the shell 802, the window 818 region being affixedto the shell 802, the aperture 818 comprising features 814 for grabbingand removing medical sharps from their handles or barrels. The lid 804can further comprise an optional suture needle counter 820.

FIG. 8B illustrates an oblique view of the Sharpshell 800 in the closedconfiguration wherein the lid or top 804 has been closed. In otherembodiments, the Sharpshell 800 can comprise a plurality of nested lids804. The Sharpshell 800 can comprise external labeling 810.

Additional views of the Sharpshell 800 are provided in FIGS. 8C-8Mwherein like numerals refer to the features and portions describedabove.

FIG. 8J shows how features 814 for grabbing and removing medical sharpsfrom their handles or barrels may provide a molded engagement structureto allow the Luer locks 841 to be snapped into place and held while thesyringe barrels are disconnected.

FIG. 8K shows how syringes 840 may be placed so as to engage hubreceiver feature 814 as the syringe needles extend into the Sharpshell800. The syringe barrels may then be removed while the syringe Luerlocks 841 remain secured in hub receiver feature 818.

FIG. 9A illustrates another embodiment of a Sharpshell 900 comprising aside wall 902, a base 904, a top 906, a plurality of syringe needleentry apertures 908, one or more suture needle apertures 910, a needlere-capping station 912, an optional foam filler 914 shown in the cutawayportion of side wall 902, a suture needle window external cover 916, asuture needle internal retention window 918, one or more jam cleats orsyringe needle retention mechanism 920, one or more scalpel bladeaperture, 922, a suture needle drop port 922 (optional where a sutureneedle internal retention aperture 918 is provided), and an anti-skidbase pad 924.

The suture needle aperture external cover 916 may be in the form of areleasable adhesive strip that may be replaced over suture needleinternal retention aperture 918 after suture needles are placed into theinternal storage volume of the Sharpshell 900 by inserting them throughsuture needle internal retention aperture 918.

The side wall 902 is shown as being axially elongate and linearlytapering from bottom to top. In other embodiments, the side wall 902 cancomprise a radially concave cross-section that is flared outward more atthe bottom than at the top. In one embodiment, side wall 902, base 904,and top 906 form a generally frusto-conical shape that has theconcomitant advantages of placement stability, convenient manualhandling by the user and ease of manufacture, such as through plasticmolding techniques. In alternative embodiments, the top 906 can comprisea flat surface, a dome surface, as shown in FIGS. 9A and 9B, a conicalsurface, a conical shape with a flat at the top (i.e., itselffrusto-conical), and the like. The side wall 902 and the top 906 (and insome embodiments the bottom 904) comprise the walls of a shell and arepuncture-resistant to medical sharps under normal loading. The side wall902, the top 906, and the bottom 904 can comprise materials such as, butnot limited to, polystyrene, PVC, ABS, PET, PETG, polyamide,polyurethane, polycarbonate, polyethylene, polypropylene, and the like.The wall thickness of the side wall, 902, top 906, and bottom 904 canrange from about 0.010 to about 0.125 with a preferred range of about0.020 to about 0.050 inches.

The foam filler 914 can completely fill the Sharpshell 900, it canpartially fill the Sharpshell 900, or it can be omitted. In alternativeembodiments, the foam filler 914 may fill the Sharpshell 900 to anextent sufficient to be presented through suture needle internalretention aperture 918 and to be encountered by syringe needles extendedthrough The foam filler 914 can comprise low density materials such aspolyurethane, polycarbonate, and the like, and can further comprisematerials with high friction and adhesive properties. The foam filler914 can comprise open celled configurations that allow for absorptionand capillary extraction and dispersal of liquids injected therein, thuspreventing any leakage from the foam to the exterior of the Sharpshell900.

The apertures 908 can comprise color coding, shape coding or othermethodology to facilitate matching with specific sized medical sharps.The aperture 908 can be configured for the removal of hypodermic needlehubs from the syringe barrels, or for grabbing the hypodermic needle andretaining it within the Sharpshell 900.

FIG. 9B illustrates a top view of the Sharpshell 900 further comprisingthe side wall 902, the top 906, the one or more syringe needle apertures908, the suture needle aperture 910, the suture needle aperture externalcover 916, and the needle recapping station 912.

One or more aperture 908 can comprise a shape configured to accept ascalpel handle, blade, or combination thereof. The aperture 908configured for a scalpel can comprise a rectangular configuration orprofile and be sized to have a friction fit with the scalpel handle. Theaperture 908, configured to accept a hypodermic needle can comprise across or X-shaped fenestration with a circular center such that asyringe needle hub will insert and catch within the aperture 908 byfriction or resistance to rotation, which can facilitate removal.

The jam cleat 920 can be affixed to the side wall 902, to the top 906,or both. The jam cleat 920 can comprise a thin sheet of hardened metalcomprising fenestrations and can be pre-bent to deflect in the directionof insertion of a hypodermic needle. In a preferred embodiment, the jamcleat 920 can comprise a small central hole, smaller than the diameterof a hypodermic needle, and a plurality of petals, ranging in numberfrom two to ten or more, that can easily deflect in one direction butnot the other. The metal thickness of the jam cleat 920 can range fromabout 0.001 to about 0.025 inches. The material can comprise stainlesssteel, hard steel, chrome steel, MP-32N titanium, nitinol, or the like.In a configuration for a scalpel blade, the jam cleat 920 can comprisetwo petals, separated along a single line, instead of three or fourlines, for example, separated by a Y or X.

The jam cleat 920 can also comprise one or more hinged projections orarms with the surfaces toward which a medical sharp is insertedcomprising one or more sharp edges, pins, needles, serrations,adhesives, or the like. The jam cleat 920 of this embodiment can bespring loaded to close against the medical sharp but be oriented suchthat the sharp can be pushed alongside the jam cleat projections whichare angled away from the medical sharp entry point. As the medical sharpis withdrawn, the jam cleat closes ever more tightly and grabs themedical sharp with increasing force.

In yet another embodiment, the jam cleat 920 can comprise polymericmaterials with a high-tack adhesive using similar configurations.However, the jam cleat 920 can also comprise a cylinder of gel oradhesive which grabs anything inserted therethrough and prevents orrestricts extraction or withdrawal therefrom.

The jam cleat 920 can be backed up with a membrane or seal that preventsany leakage outside of the Sharpshell 900. The jam cleat 920 isadvantageously positioned so that an inserted sharp, having a handle,hub or barrel, extends sufficiently through the aperture 908 and througha sharps removal feature, but does not extend into the jam cleat 920,which is configured to accept and catch only on narrow or small diameterobjects such as the hypodermic needle or scalpel blade. Thus, there maybe a space between the aperture 908 and the jam cleat 920.

The Sharpshell 900, is configured to be small, available at the point ofuse, compact, stable, and provides a secure method to increasehealthcare staff needlestick safety. The Sharpshell 900 can be deliveredwithin a medical procedure kit, or it can be provided separately. TheSharpshell 900 can be provided sterilized so it can be placed within thesterile field, which is generally the point of use. The Sharpshell 900can be separated from a procedure kit to facilitate disposal in thesmallest possible envelope. The Sharpshell 900 facilitates thecollection and safe transport of contaminated medical sharps to arequired disposal facility station. The Sharpshell 900 can bemanipulated with one hand so another hand is not needed to stabilize itwhile inserting medical sharps.

The top cap 906 can be flattened around the needle re-capping station912 to differentiate this port 912 of the Collection and ContainmentStation and to facilitate its use during a medical procedure. There-capping port 912 can also comprise internal grooves or ridges tomatch the design of the hand grips on typical needle caps

The ports 908 for the hypodermic syringes are on the curved portion ofthe top cap 906 to orient and direct the medical sharps to the center ofthe containment chamber 914. Also the port 908 can comprise an about ⅛″to ¼″ long internal flange, wider at the top with grooves and narrowingat the bottom to accommodate, tightly grip, and facilitate removal ofvarious sizes of typically available needle hubs.

The suture needle drop port 922 can be round, as illustrated, orelongated, elliptical, or the like, and covers part of the top cap 906and part of the side 902 to differentiate its function from other portsof the Sharpshell 900 and allows for convenient and stable, one handed,insertion and drop of needles and sutures when using standard sutureholding devices. The suture needle drop port 900 can further comprise acovering of elastomeric material, adhesives, or the like.

The scalpel port can be located on the curved portion of the top cap 906and can be elongated to differentiate its function from that of thesuture drop port 922, hypodermic needle ports 908, or the recapping port912. The scalpel port can also comprise an about ⅛″ to ¼″ moldedinternal flange, wider at the top to accommodate various sizes anddesigns of scalpels and to provide additional support for collection andcontainment

Optionally covering the inside of the top cap 906 can include a flexiblecoating such as a gel/silicone type material to facilitate retention ofthe contaminated sharps. Opening around the suture drop is typicallyuncoated to facilitate dropping to the bottom. The bottom however, canalso be coated with the flexible coating gel/silicone to help retain anysharps entering the containment chamber.

In a preferred embodiment, appropriate surfaces near the ports arelabeled to indicate preferred use.

An external label can be attached to the side of the Sharpshell 900 toindicate the product name, instructions for use, warnings, cautions, andBIOHAZARD symbol warnings.

FIGS. 9C-9G provide additional photographic views of the Sharpshell 900of FIGS. 9A and 9B in various stages of use during a medical or surgicalprocedure.

FIG. 10 illustrates a Sharpshell 1000 in oblique view. The Sharpshell1000 comprises a non-openable shell 1002 further comprising a centralvolume 1018, a standoff 1004 comprising a first receiver 1016 for aneedle exchange cap, a needle exchange cap backstop 1006, a stabilizer1008, a suture needle slot 1010, a scalpel blade receiver 1012, and aplurality of hypodermic needle receivers 1014.

Referring to FIG. 10, the first receiver 1016 can comprise an openingthat is circular or rectangular that allows for horizontal needleparking and recapping. The syringe needle cap can be placed between theopening and the solid backstop manually or by sliding off of thesyringe. Recapping can be performed, single handed, by holding thesyringe and sliding the sharp point into the supported cap holder. Thefirst receiver 1016 opening can be horizontal or vertical, depending ondesired use.

The needle exchange cap backstop 1006 or resting block can also providestability support for the unit when it is standing vertically to acceptneedles, scalpels, or the like. The backstop 1006, in the illustratedembodiment, can provide horizontal stability to prevent tipping of theSharpshell 1000. The combination of receiving space and back restprovide elevated and secure support for inserting sutures through thetop opening of the first receiver 1016.

The suture needle slot 1010 is optimized for depositing suture needlestherein. The suture needle slot 1010 can be located on the top surfaceof the device, as illustrated. The suture needle slot 1010 can comprisewalls which are graduated oblique to the axis of the slot 1010. In thisembodiment, the outermost portion of the slot 1010 can be wider ornarrower than the innermost portion of the slot 1010. The slot oropening 1010 can have flat edges or graduate towards the center toprevent sutures from falling back out. The slot 1010 can also beconfigured to taper toward the edge to allow for trimming of suturematerial. Once the suture needle has been inserted through the slot1010, it resides within the central volume or hollow cavity 1018. Thecavity 1018 can be hollow or filled with various types of foam, gel,fibrous materials, or the like. In some embodiments, the cavity 1018 canbe completely filled with foam, gel, or the like, or the cavity 1018 cancomprise a volume 1018 that is partially filled with foam, gel,adhesives, or the like, to allow for the sutures to drop into the cavitybut still for liquid absorption and retention of other sharps.

Referring to FIG. 10, the top surface of the shell 1002 can be flat (asillustrated) or slightly curved, either convex or concave.

The slot 1012 can be configured for grasping and capturing scalpelblades. The slot 1012 can be rectangular as shown, or it can be taperedor have uneven walls which facilitate grasping the scalpel handle,blade, or the like. The slot 1012 can comprise an opening that providesfor friction, interference or mechanical grip on the scalpel whereby theentire sharp end is secured within the device's cavity. The slot oropening 1012 can also be used to discard of sutures if the user desiresto stand the unit up on the short end during use. Sutures stored throughthis opening 1012 will not preclude a scalpel from also being stored inthis location.

The hypodermic needle receivers 1014 can comprise circular openings with2-4 teeth protruding into lumen for needle capture and removal. Theteeth can be configured to dig into, and hold, a syringe needle hubwhile unscrewed from its syringe barrel. The teeth can be configured asa star pattern, a cross, an X, or in a pattern of two or three teethequally spaced around the circumference. The length of the teeth(projection into the opening or slot) is such that when a needle isinserted into the cavity, the teeth secure the needle from spinningfreely so that the needle can be unscrewed from the syringe safety andwith one hand.

The opening, receiver, or slot 1014 may also have no teeth, but use afriction, interference or mechanical grip on the needle or needle barrelto achieve the same objective.

The Sharpshell 1000 can comprise dimensions suitable for portability andtransport. The opening 1012 on the front face can comprise approximatelya 7/16″× 3/16″ rectangle cutout for securing of a scalpel.

The syringe needle retention receivers 1014 can comprise one or moreapproximately 3/16″ diameter cutouts with 2 or more optional 1/32″ teetheach that are designed to catch and release needles from a syringebarrel.

The slot 1010 can comprise approximately a 1/16″×¾″ rectangle cutout ontop for insertion of used suture needles. These dimensions can betailored to meet the requirements of different types of suture needles.Needles can be dropped into the cavity 1018 and retained therein. Astrip of tape or other closure can be used to secure the openings in theSharpshell against egress of medical sharps trapped therein.

The recapping feature 1016 can comprise approximately a ¼″ diameter holefor cap placement and recapping of needles with backstop materialapproximately 1″ (range 0.5 to 1.5″) away preventing needle cap frompushing all the way through.

The main cavity 1018, in the illustrated embodiment comprises dimensionsof about 1.125″×2.5″×⅝″. These dimensions can be adjusted to meet theneeds of various types of medical sharps.

Referring to all embodiments described herein, a receiver can be termeda port, a window, an aperture, a fenestration, a slot, a hole, anopening, or any structure that permits access to the interior of theSharpshell containment cavity or region behind a receiver. The termwindow, if defined as such, can also comprise a visually transparentpanel over an opening that permits viewing of objects on the other sideof the window.

FIG. 11 illustrates a Sharpshell 1100 in the open configuration inoblique view. The Sharpshell 1100 comprises a shell 1102 furthercomprising a bottom portion 1104, a top portion 1106, a hinge 1108, astandoff 1126 comprising a first receiver 1110 for a needle exchangecap, a needle exchange cap backstop 1112, a scalpel receiver 1114, aplurality of hypodermic needle receivers 1116, a bottom central volume1118, a top central volume 1126, a bottom foam pad 1120, an optional topfoam pad 1122 (not shown), and a closure lock 1124.

Referring to FIG. 11, the Sharpshell Unit 1100 is composed of twohalves: a top portion 1106 comprising a shallow clear puncture resistantcavity 1126 and a needle cap storage and placement device, and a bottomportion 1104 comprising a deeper cavity 1118 with storage and removalapparatus for suture, needles and scalpels.

The top portion 1106 comprises a shallow top cavity 1126 which caneither be filled with foam or polypropylene or be left empty so that theuser can see through to the sutures stored in the bottom cavity 1118.Materials filling the top cavity 1126, bottom cavity 1118, or both,would provide moisture absorption as well as further protect and securethe sharps in the device.

The needle cap storage and recapping feature can comprise an opening1110 that can either be circular or rectangular that allows forhorizontal needle parking and recapping. The syringe needle cap can beplaced between the opening and the solid backstop 1112 manually or bysliding it off of the syringe barrel. Recapping can be performed bysingle handed by holding the syringe and sliding the sharp point intothe supported cap holder. The recapping opening 1110 can be positionedor oriented either horizontal or vertical, depending on desired use.

The backstop 1112 can serve as a resting block for the Sharpshell 1100to provide stability support for the Sharpshell 1100 unit, open orclosed, when it is standing vertically to accept needles, or scalpels,or the like. The combination of receiving space 1110 and the back rest1112 provide elevated and secure support for inserting sutures throughthe top opening.

The bottom portion 1104 is configured or adapted to hold and retainsuture needles, with or without their sutures attached. The bottomcavity 1118 can be hollow or filled, in part or in whole, with varioustypes of foam, gel, adhesive, fibers, or the like. The filler materialor pads 1120 within the bottom cavity 1118 can be visually divided,using labels, shell material barriers or webs, or the like, to allow forplacement and counting of the sutures inserted into the material. TheSharpshell 1100 comprises openings on the front face of the bottomportion 1104 of the unit.

The scalpel receiver 1114 comprises an opening that provides forfriction, interference or mechanical grip on the scalpel whereby theentire sharp end is secured within the device's cavity 1118. The opening1114 can also be used to discard of sutures if the user desires to standthe unit up on the short end during use. Sutures inserted through thisopening 1114 will not preclude a scalpel from also being inserted andstored in this location.

The one or more syringe or hypodermic needle receivers 1116 can comprisecircular openings, for example with about 2-4 teeth protruding intolumen for needle capture and removal. The teeth can be adapted to diginto and hold needle hub while unscrewed from syringe base. Thehypodermic needle receivers 1116 can comprise star shaped patterns,X-patterns, diamond patterns, or the like, all configured to accept asyringe needle hub and prevent rotation of the hub while the barrel isbeing removed.

The top portion 1106 and the bottom portion 1104 are affixed to eachother and operably connected via a living or mechanical hinge 1108.

Closure of the top portion 1106 against the bottom portion 1104 can beperformed through locking mechanisms such as, but not limited to, a snapand hook, penetrating hook, or pressure fit mechanism. Closure can alsobe maintained using adhesives affixed to the flanges 1128 and 1130surrounding the top portion 1106 and the bottom portion 1104. Theadhesives can be protected using release paper prior to use.Additionally a double wall feature can be created by the overlaying ofthe top portion 1106 and portion 1104 to prevent liquid leakage andfurther enclose the sequestered sharps.

The size of the Sharpshell 1100 is adapted for compactness and ease oftransport. The scalpel receiver comprises an approximately rectangularopening of about 7/16″× 3/16″ dimensions for securing a scalpel.

The syringe needle receiver can comprise between 1 and 6 each,approximately 3/16″ diameter cutouts with between 1 and 4 inwardprojections about 1/32 inch long.

The openings on front face of top half of unit can be sized as openingsof approximately ¼″ diameter adapted for cap placement and recapping ofneedles with the backstop 1112 material located about 1″ away.

FIG. 12 illustrates a Sharpshell 1200 in oblique view. The Sharpshell1200 comprises an axially elongate structure having a top 1202, a bottom1204, and a side wall 1206. The top 1202 can comprise a scalpel bladereceiver 1208, a plurality of hypodermic needle receivers 1210, and aneedle recapping receiver 1212. The Sharpshell 1200 further comprises acentral volume 1214.

Referring to FIG. 12, the scalpel blade receiver 1208 can furtherreceive suture needles. The side wall 1206 can comprise a curvilinearcontour, as shown. The curvilinear contour permits a wide base forincreased or enhanced stability, strength, and rigidity of thestructure, relative to straight side walls 1206. The side wall 1206, thetop 1202, and the bottom 1204 can be transparent, translucent, opaque ora combination thereof. The side wall 1206, the top 1202, and the bottom1204 can comprise labeling, instructions for use, warnings, and thelike.

The central volume 1214, containment cavity, hollow space, or hollowcavity serves the purpose of or provides for depositing suture needleswithin the Sharpshell 1200.

The Sharpshell 1200 can comprise dimensions suitable for carrying in thehand and small enough to fit within permanent sharps disposalcontainers. In the illustrated embodiment, the Sharpshell 1200 comprisesa diameter of about 1 inch at the top, about 2 inches at the base, and aheight of about 2.25 inches. The top diameter can range from about 0.5inches to about 2 inches. The bottom diameter can range from about 0.75inches to about 3 inches. The height can range from about 1 inch toabout 3 inches. The edges are beneficially rounded or filleted, forexample with radii of about 0.02 to about 0.1 inches.

The needle recapping receiver can comprise a diameter of about 0.2 toabout 0.3 inches. The diameter is configured to accept a syringe needlecap approximately ½ or more inserted into the central cavity and with apress or friction fit to enhance stability but still allow removal ofthe cap.

The scalpel port or receiver can comprise dimensions of about 7/16″ longby 3/16″ wide and can comprise a cutout for securing of scalpel andinsertion of used suture needles. Needles are dropped into the cavityfirst then scalpel is inserted and locked into place.

The one or more hypodermic needle or syringe needle receiver 1210 cancomprise holes or fenestrations of about 3/16″ diameter, ranging fromabout 0.1 to about 0.2 inches in diameter. The syringe needle receivers1210 can comprise cutouts with one or more teeth each that are designedto catch and release needles from a syringe. The teeth, in theillustrated embodiment, can comprise dimensions of about 1/32 inches.

The syringe needle receivers 1210 can further comprise jam cleats orother features to irreversibly prevent removal of a syringe needleinserted therethrough and can further comprise seal features to preventfluid escape through the needle receivers 1210 or any other port.

FIG. 13A illustrates another embodiment of a Sharpshell 1300 which maybe considered a variant of Sharpshell 900 and 1200 described above, andcomprising a side wall 1302, a base 1304, a top 1306, a plurality ofsyringe needle entry apertures or “windows” 1308, one or more sutureneedle windows, such as suture needle window 1310, a needle re-cappingstation 1312, an optional foam filler 1314 shown in the cutaway portionof side wall 1302 and exposed by suture needle window 1310, a sutureneedle window external cover 1316 which may provide a removable cover tosuture needle window 1310, one or more teeth or protrusions or syringeneedle retention mechanism 1320, one or more scalpel blade window 1322,and an anti-skid base pad 1324.

The suture needle window external cover 1316 may be in the form of areleasable adhesive strip that may be replaced over suture needle window1310 after suture needles are placed into the internal storage volume ofthe Sharpshell 1300 by inserting them through suture needle window 1310.

The side wall 1302 is shown as being axially elongate and linearlytapering from bottom to top. In other embodiments, the side wall 1302can comprise a radially concave cross-section that is flared outwardmore at the bottom than at the top. In one embodiment, side wall 1302,base 1304, and top 1306 form a generally frusto-conical shape that hasthe concomitant advantages of placement stability, convenient manualhandling by the user and ease of manufacture, such as through plasticmolding techniques. In alternative embodiments, the top 1306 cancomprise a flat surface, a dome surface, as shown in FIGS. 13A and 13B,a conical surface, a conical shape with a flat at the top (i.e., itselffrusto-conical), and the like. The side wall 1302 and the top 1306 (andin some embodiments the bottom 1304) comprise the walls of a shell andare puncture-resistant to medical sharps under normal loading. The sidewall 1302, the top 1306, and the bottom 1304 can comprise materials suchas, but not limited to, polystyrene, PVC, ABS, PET, PETG, polyamide,polyurethane, polycarbonate, polyethylene, polypropylene, and the like.The wall thickness of the side wall, 1302, top 1306, and bottom 1304 canrange from about 0.010 to about 0.125 with a preferred range of about0.020 to about 0.050 inches.

The optional foam filler 1314 can completely fill the Sharpshell 1300,it can partially fill the Sharpshell 1300, or it can be omitted. Inalternative embodiments, the foam filler 1314 may fill the Sharpshell1300 to an extent sufficient to be presented through suture needlewindow 1310 and to be encountered by syringe needles extended throughthe window. The foam filler 1314 can comprise low density materials suchas polyurethane, polycarbonate, and the like, and can further comprisematerials with high friction and adhesive properties. The foam filler1314 can comprise open celled configurations that allow for absorptionand capillary extraction and dispersal of liquids injected therein, thuspreventing any leakage from the foam to the exterior of the Sharpshell1300.

The needle windows, such as suture needle window 1310, can comprisecolor coding, shape coding or other methodology to facilitate matchingwith specific sized medical sharps. The windows, such as hypodermicneedle window 1308, can be configured for the removal of hypodermicneedle hubs from the syringe barrels, or for grabbing the hypodermicneedle and retaining it within the Sharpshell 1300.

FIG. 13B illustrates a top view of the Sharpshell 1300 furthercomprising the side wall 1302, the top 1306, the one or more syringeneedle windows 1308, the suture needle window 1310, the suture needlewindow external cover 1316, and the needle recapping station 1312.

One or more window 1322 can comprise a shape configured to accept ascalpel handle, blade, or combination thereof. The window 1322configured for a scalpel can comprise a rectangular configuration orprofile and be sized to have a friction fit with the scalpel handle. Thewindow(s) 1308, configured to accept a hypodermic needle can comprise across or X-shaped fenestration with a circular center such that asyringe needle hub will insert and catch within the window(s) 1308 byfriction or resistance to rotation, which can facilitate removal. Thesewindows may also be in the form of a two-toothed design as shown in FIG.13A.

The jam cleat 1320 can be affixed to the top 1306. The jam cleat 1320can comprise a thin sheet of hardened metal comprising fenestrations andcan be pre-bent to deflect in the direction of insertion of a hypodermicneedle. In a preferred embodiment, the jam cleat 1320 can comprise asmall central hole, smaller than the diameter of a hypodermic needle,and a plurality of petals, ranging in number from two to ten or more,that can easily deflect in one direction but not the other. The metalthickness of the jam cleat 1320 can range from about 0.001 to about0.025 inches. The material can comprise stainless steel, hard steel,chrome steel, MP-32N titanium, nitinol, or the like. In a configurationfor a scalpel blade, the jam cleat 1320 can comprise two petals,separated along a single line, instead of three or four lines, forexample, separated by a Y or X.

The jam cleat 1320 can also comprise one or more hinged projections orarms with the surfaces toward which a medical sharp is insertedcomprising one or more sharp edges, pins, needles, serrations,adhesives, or the like. The jam cleat 1320 of this embodiment can bespring loaded to close against the medical sharp but be oriented suchthat the sharp can be pushed alongside the jam cleat projections whichare angled away from the medical sharp entry point. As the medical sharpis withdrawn, the jam cleat closes ever more tightly and grabs themedical sharp with increasing force.

In yet another embodiment, the jam cleat 1320 can comprise polymericmaterials with a high-tack adhesive using similar configurations.However, the jam cleat 1320 can also comprise a cylinder of gel oradhesive which grabs anything inserted therethrough and prevents orrestricts extraction or withdrawal therefrom.

The jam cleat 1320 can be backed up with a membrane or seal thatprevents any leakage outside of the Sharpshell 1300. The jam cleat 1320is advantageously positioned so that an inserted sharp, having a handle,hub or barrel, extends sufficiently through the window 1308 and througha sharps removal feature, but does not extend into the jam cleat 1320,which is configured to accept and catch only on narrow or small diameterobjects such as the hypodermic needle or scalpel blade. Thus, there maybe a space between the window 1308 and the jam cleat 1320.

The Sharpshell 1300, is configured to be small, available at the pointof use, compact, stable, and provides a secure method to increasehealthcare staff needlestick safety. The Sharpshell 1300 can bedelivered within a medical procedure kit, or it can be providedseparately. The Sharpshell 1300 can be provided sterilized so it can beplaced within the sterile field, which is generally the point of use.The Sharpshell 1300 can be separated from a procedure kit to facilitatedisposal in the smallest possible envelope. The Sharpshell 1300facilitates the collection and safe transport of contaminated medicalsharps to a required disposal facility station. The Sharpshell 1300 canbe manipulated with one hand so another hand is not needed to stabilizeit while inserting medical sharps.

The top cap 1306 can be flattened around the needle re-capping station1312 to differentiate this port 1312 of the Collection and ContainmentStation and to facilitate its use during a medical procedure. There-capping port 1312 can also comprise internal grooves or ridges tomatch the design of the hand grips on typical needle caps

The ports 1308 for the hypodermic syringes are on the curved portion ofthe top cap 1306 to orient and direct the medical sharps to the centerof the containment chamber 1314. Also the port 1308 can comprise anabout ⅛″ to ¼″ long internal flange, wider at the top with grooves andnarrowing at the bottom to accommodate, tightly grip, and facilitateremoval of various sizes of typically available needle hubs; or the port1308 may also be in the form with protruding teeth into the window, suchas the two-toothed design as shown in FIG. 13A.

The scalpel port 1322 can be located on the curved portion of the topcap 1306 and can be elongated to differentiate its function from that ofhypodermic needle ports 1308 or the recapping port 1312. The scalpelport 1322 can also comprise an about ⅛″ to ¼″ molded internal flange,wider at the top to accommodate various sizes and designs of scalpelsand to provide additional support for collection and containment

Optionally covering the inside of the top cap 1306 can include aflexible coating such as a gel/silicone type material to facilitateretention of the contaminated sharps. Opening around the suture drop istypically uncoated to facilitate dropping to the bottom. The bottomhowever, can also be coated with the flexible coating gel/silicone tohelp retain any sharps entering the containment chamber.

In a preferred embodiment, appropriate surfaces near the ports arelabeled to indicate preferred use.

An external label can be attached to the side of the Sharpshell 1300 toindicate the product name, instructions for use, warnings, cautions, andBIOHAZARD symbol warnings.

FIGS. 13C-13G provide additional views of the Sharpshell 1300 of FIGS.13A and 13B in various stages of use during a medical or surgicalprocedure.

The devices described herein, can all comprise a syringe needle exchangearea, which can comprise a well into which a syringe needle cap can beinserted and which ideally prevents rotation of the syringe needle capwithin a collection pad or shell structure. The syringe needle exchangearea is ideally oriented vertically with respect to a planar surfacewhich can rest stable on a table top. A syringe needle is insertedwithout requiring a hand to hold the Sharpshell to prevent inadvertentlysticking the syringe needle into a hand. In other embodiments, thesyringe needle exchange area can comprise a built in structure similarto a syringe needle cap, which is an axially elongate hollow structurecomprising a center lumen and a cross or X structure to grab theexterior of a syringe needle hub by friction or press fit.

Application of the Sharpshell system and methods reduces the risk that amedical caregiver will use a hypodermic needle, scalpel, or the like ona patient, turn around and accidentally stab a co-worker while trying toput the sharp into its receptacle. Such a scenario is particulardisadvantageous when the patient is a vector for highly pathogenicorganisms such as those for hepatitis, human immunodeficiency virus(HIV), and the like. The Sharpshell system is universal and does notrequire that each individual sharp is specially designed to retract orself-blunt. The Sharpshell and the methods of using the Sharpshellreduce the risk of an inadvertent contamination in the medicalenvironment. The Sharpshell system can be provided within a hospital,emergency vehicle, or medical center but it can also be provided at anypoint of use outside a hospital or traditional medical center wheremedical intervention is provided.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. For example, theSharpshell can, instead, be configured as a single monolithic slab ofgel material that entraps the sharp and hardens to embed the sharp. TheSharpshell receptacle and dispenser may also be configured to acceptsuch hardenable gel. The described embodiments are to be considered inall respects only as illustrative and not restrictive. Featuresdescribed for a given embodiment can be applied to other embodimentsdisclosed herein while remaining within the scope of the disclosure.Materials and dimensions specified for a given embodiment may also beused for other embodiments described herein. The scope of the inventionis therefore indicated by the appended claims rather than the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

1. An apparatus adapted for entrapment and disposal of medical sharpscomprising: a shell defining a storage volume, said shell having a topportion, a side wall portion and a bottom base portion, the base portionbeing at least as large in area as said top portion, said shell adaptedto stand upright upon said base so as to present an exposed said topportion and an exposed said side wall portion; said top portioncomprising (a) at least one syringe cap holding aperture adapted toreleasably accept a syringe cap so as to allow a capped syringe to bereleasably extended into said storage volume and (b) at least onesyringe capture aperture adapted to capture and hold a syringe hub asits syringe needle extends into said storage volume; (c) at least onescalpel capture aperture adapted to capture and hold a scalpel as itsblade extends into said storage volume; and wherein said shell comprisesa suture needle aperture adapted to receive suture needles into saidstorage volume.
 2. An apparatus according to claim 1 additionallycomprising a high-friction pad contained within said shell and exposedthrough said at least one syringe capture and said suture needleaperture.
 3. An apparatus according to claim 1 wherein said side wallportion comprises said suture needle aperture.
 4. An apparatus accordingto claim 4, additionally comprising a releasable cover piece coveringsaid suture needle aperture.
 5. An apparatus according to claim 5wherein said releasable cover piece comprises a releasable adhesivestrip.
 6. An apparatus according to claim 1 wherein said base portion isof a material adapted to resist sliding friction as compared to thematerial comprised by said a top portion and side wall portion.
 7. Anapparatus according to claim 1, said apparatus contained within aprocedure tray or kit.
 8. An apparatus according to claim 1, saidapparatus affixed to a procedure tray or kit.
 9. An apparatus accordingto claim 1 wherein at least a portion of said shell is transparent.claims to FIG. 12 Embodiment
 10. An apparatus adapted for entrapment anddisposal of medical sharps comprising: a shell defining storage volume,said shell having a top portion, a side wall portion and a bottom baseportion, the base portion being at least as large in area as said topportion, said shell adapted to stand upright upon said base so as topresent an exposed said top portion and an exposed said side wallportion; said top portion comprising (a) at least one syringe captureaperture adapted to capture and hold a syringe Luer fitting as itssyringe needle extends into said storage volume; and (b) a suture needleand scalpel aperture adapted to receive suture needles and scalpelblades into said storage volume.
 11. An apparatus according to claim 10additionally comprising a foam portion contained within said shell andexposed through said at least one syringe capture and said suture needleaperture.
 12. An apparatus according to claim 10, additionallycomprising a releasable cover piece covering said suture needle andscalpel aperture.
 13. An apparatus according to claim 12 wherein saidreleasable cover piece comprises a releasable adhesive strip.
 14. Anapparatus according to claim 10 wherein said base portion is of amaterial adapted to resist sliding friction as compared to the materialcomprised by said a top portion and side wall portion.
 15. An apparatusaccording to claim 10 additionally comprising at least one syringe capholding aperture adapted to releasably accept a syringe cap so as toallow a capped syringe to be releasably extended into said storagevolume.
 16. An apparatus according to claim 10, said apparatus containedwithin a procedure tray or kit.
 17. An apparatus according to claim 10,said apparatus affixed to a procedure tray or kit.
 18. An apparatusaccording to claim 10 wherein at least a portion of said shell istransparent. claims to FIG. 13 Embodiment 19.-35. (canceled)